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Adverse Event Report

ACS/DVI HI-TORQUE BALANCE GUIDE WIRE   back to search results
Catalog Number 28000
Event Date 02/05/1997
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

After admitting the patient with new onset chest paint and elevated cardiac enzymes an angiogram was performed. The lad reportedly appeared hazy. The patient was started on reopro (thrombolytic agent) and a ptca/stent procedure of the lad was performed. The physician reported the procedure was unremarkable and the patient was stable throughout. However, post-procedure the patietn became hemodynacially unstable and was found to have a pericardial effusion. A pericardicentesis was performed. Ultimately the patient went to surgery where a hole was found in a distal diagonal branch which was believed to have been caused by the guidewire via a communication from the distal lad to the distal diagonal branch.

 
Manufacturer Narrative

The information in section f is provided by the mfr. F6: unk. F9: unk. F10: type of event addressed in the labeling: patient code: 2226, 2135, and 2357 (not labeled) device code: no device failure reported. During processing of this complaint qa attempted to obtain complete information of the event and patient status from the hospital, distributor or field contact as appropriate.

 
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Brand NameHI-TORQUE BALANCE GUIDE WIRE
Type of DeviceGUIDE WIRE
Baseline Brand NameHIGH-TORQUE BALANCE GUIDEWIRE
Baseline Generic NameGUIDE WIRE
Baseline Catalogue Number28000
Baseline Device FamilyGUIDE WIRE
Baseline Device 510(K) NumberK925381
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed02/04/1993
Manufacturer (Section F)
ACS/DVI
26531 ynez rd
temecula CA 92591
Manufacturer (Section D)
ACS/DVI
26531 ynez rd
temecula CA 92591
Manufacturer (Section G)
ABBOTT VASCULAR-CARDIAC THERAPIES
26531 ynez rd.
mailing p.o. box 9018
temecula CA 92589 9018
Manufacturer Contact
charles mcendree
26531 ynez rd
temecula , CA 92591-4628
(909) 914 -2050
Device Event Key76223
MDR Report Key76493
Event Key72048
Report Number2024168-1997-00039
Device Sequence Number1
Product CodeDQX
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/12/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/12/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date06/06/1997
Device Catalogue Number28000
OTHER Device ID Number305989-001
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Agena
Event Location Hospital
Date Manufacturer Received02/10/1997
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/12/1997 Patient Sequence Number: 1
#TreatmentTreatment Date
1,NTG, ASPIRIN, HEPARIN AND REOPRO WERE ADMINSTERED,02/05/1997
2 PRIOR AND DURING PROCEDURE. 02/05/1997

Database last updated on January 30, 2009

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