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Adverse Event Report

EP TECHNOLOGIES, INC. CONSTELLATION ADVANCED MAPPING CATHETER ADVANCED DIAGNOSTIC MAPPING CATHETER   back to search results
Model Number 8031
Event Date 06/10/2004
Event Type  Other   Patient Outcome  Hospitalization; Other Required Intervention
Event Description

Pt underwent an electrophysiology procedure to have an ablation for artrial fibrillation. Diagnostic catheters were inserted into the coronary sinus (cs) and the right ventricle (rv). An acuson intracardiac echocardiographic (ice) catheter was inserted and positioned in the right atrium. The constellation diagnostic catheter was inserted in the left atrium via a transseptal puncture using a convoy sheath. Using ice guidance, the physician targeted the convoy sheath into the left inferior pulmonary vein (lipv), then deployed the constellation. As evidenced on fluoroscopy, the basket distal tip of the constellation catheter appeared to be "pinched" circumferentially. The physician removed the constellation from the targeted area of the lipv and then repositioned the sheath/constellation assembly into the left superior pulmonary vein. At this point, the pt developed bradycardia with a heart rate of 20 bpm with no blood pressure. Treatment of the event, believed at this time to be a vasovagal reaction, included atropine, temporary pacing, heparin reversal, and fluid administration. Pt stabilized. However, further assessment with the ice catheter, still positioned in the right atrium, revealed a pericardial effusion (presumably as a result of a catheter perforation) requiring a pericardialcentesis. The pt appeared stable with a heart rate of 70 bpm and a blood pressure of 130/70mm hg. Nonetheless, a surgical consultation was requested. The blazer xp catheter was inserted but no ablation occurred. Retrospectively, the perforation was believed to have resulted from the constellation deployed in the left atrial appendage rather than the targeted lipv as evidenced by the "pinched" effect on the basket distal tip. In 06/2004, an ep technologies, inc. Sales rep visited the facility and determined the pt had not requried surgery, was fine and released the next day.

 
Manufacturer Narrative

Device was discarded by the facility, therefore an evaluation of the actual device could not be performed. There was no info to suggest device malfunction. The device lot history record was reviewed with no suggestion of problems during manufacturing. Therefore, no further device evaluation was pursued. Perforation is a known risk of the procedure.

 
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Brand NameCONSTELLATION ADVANCED MAPPING CATHETER
Type of DeviceADVANCED DIAGNOSTIC MAPPING CATHETER
Baseline Brand NameCONSTELLATION ADVANCED MAPPING CATHETER
Baseline Generic NameADVANCED DIAGNOSTIC MAPPING CATHETER
Baseline Catalogue NumberM004 US8031 0
Baseline Model Number8031
Baseline Device FamilyADVANCED DIAGNOSTIC MAPPING CATHETERS
Baseline Device 510(K) NumberK983171
Baseline Device PMA NumberK003782
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)30
Date First Marketed02/14/2001
Manufacturer (Section F)
EP TECHNOLOGIES, INC.
san jose CA *
Manufacturer (Section D)
EP TECHNOLOGIES, INC.
san jose CA *
Manufacturer Contact
christopher devine, manager
2710 orchard parkway
san jose , CA 95134
(408) 895 -3389
Device Event Key521757
MDR Report Key532488
Event Key505543
Report Number2939222-2004-00026
Device Sequence Number1
Product CodeMTD
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/10/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date09/01/2006
Device MODEL Number8031
Device Catalogue NumberM004US80310
Device LOT Number6413712
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/10/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/02/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
1,EP TECHNOLOGIES, INC. PRODUCTS: CONVOY SHEATH KIT,
2,(MODEL 5676ST, LOT# F10383) AND BLAZER XP CATHETER,
3,(MODEL 4500THK2, LOT #6367154)
,
4,ACUSON INTRACARDIAC ECHOCARDIOGRAPHIC (ICE) (MODEL,
5,NUMBER UNK)
CORONARY SINUS AND RIGHT VENTRICLE,
6,DIAGNOSTIC EP CATHETERS (MFRS AND MODEL NUMBERS,
7,UNK).,

Database last updated on January 30, 2009

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