FDA Adverse Event
Injury
Summary report: N
NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
MDR report key: 3011332
·
Received March 19, 2013
Report
- Report Number
- 9673241-2013-00080
- Event Type
- Injury
- Date Received
- March 19, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 4, 2013
- Manufacturer
- BIOSENSE WEBSTER, INC. (JUAREZ)
- Product Code
- OAD
- PMA / PMN Number
- P030031
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST FOR THE COMPLAINT PRODUCT TO BE RETURNED FOR ANALYSIS. THIS DEVICE WAS NOT RETURNED FOR INVESTIGATION AS INITIALLY REPORTED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
DURING RF IN LEFT ATRIAL, A CARDIAL TAMPONADE WAS DETECTED. TWO PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS HOSPITALIZED TO FOLLOW UP PATIENT PROGRESS. MULTIPLE ATTEMPTS WERE DONE TO REQUEST FOR FURTHER DETAILS OF THE EVENT AND THE PATIENT'S UPDATED HEALTH STATUS, HOWEVER NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 114508 | NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER | OAD | BIOSENSE WEBSTER, INC. (JUAREZ) | D-1197-17-S | 15427390M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R | EXT REF PATCH ((B)(4) LOT15671316L) |