FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

EP TECHNOLOGIES THERMISTOR EXTENDED DISTAL STEERO-CATH BIOAIRECTIONAL STEERABLE ABLATION CATH 8 FR/4MM 7 FR 110CM   back to search results
Model Number 6304
Event Date 04/01/1997
Patient Outcome  Required Intervention;
Event Description

During cardiac ablation, ablation catheter did not function properly-charred on 3rd band. Procedure completed with another catheter. Pt stable after procedure.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameTHERMISTOR EXTENDED DISTAL STEERO-CATH
Type of DeviceBIOAIRECTIONAL STEERABLE ABLATION CATH 8 FR/4MM 7 FR 110CM
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
EP TECHNOLOGIES
350 potrero ave
sunnyvale CA 94086
Manufacturer (Section D)
EP TECHNOLOGIES
350 potrero ave
sunnyvale CA 94086
Device Event Key104659
MDR Report Key106464
Event Key100077
Report Number106464
Device Sequence Number1
Product CodeLPB
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/17/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/15/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date01/01/1999
Device MODEL Number6304
Device LOT Number7A297
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/17/1997
Distributor Facility Aware Date04/14/1997
Device Ageunknown
Event Location Invalid Data
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on February 28, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH