FDA Adverse Event
Injury
Summary report: N
THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
MDR report key: 3172675
·
Received June 17, 2013
Report
- Report Number
- 9673241-2013-00195
- Event Type
- Injury
- Date Received
- June 17, 2013
- Date of Event
- May 23, 2013
- Report Date
- May 24, 2013
- Manufacturer
- BIOSENSE WEBSTER, INC. (JUAREZ)
- Product Code
- LPB
- PMA / PMN Number
- P030031/S025
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST FOR THE COMPLAINT PRODUCT TO BE RETURNED FOR ANALYSIS. PRODUCT WAS NOT RETURNED FOR INVESTIGATION. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. (B)(4).
Description of Event or Problem · 1
DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, IT WAS REPORTED THERE WAS AN ACUTE CARDIAC PERFORATION OF THE LEFT ATRIAL APPENDAGE DURING LEFT ATRIAL ABLATION AND MAPPING WHICH RESULTED IN TAMPONADE. THIS REQUIRED AN URGENT STERNOTOMY AND PERICARDIAL EVACUATION. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY RESECTED. THIS PROLONGED PATIENT¿S HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273370 | THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER | CARDIAC ABLATION PERCUTANEOUS CATHETER | LPB | BIOSENSE WEBSTER, INC. (JUAREZ) | D-1313-00 | UNKNOWN_TCOOL SF C3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Hospitalization| L| R| S |