FDA Adverse Event
Injury
Summary report: N
NAVISTAR DS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER
MDR report key: 1192802
·
Received October 8, 2008
Report
- Report Number
- 2029046-2008-00033
- Event Type
- Injury
- Date Received
- October 8, 2008
- Date of Event
- August 6, 2008
- Report Date
- August 7, 2008
- Manufacturer
- BIOSENSE WEBSTER, INC (IRWINDALE)
- Product Code
- OAD
- PMA / PMN Number
- P010068
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CATHETER PASSED VISUAL TEST AND ELECTRICAL TEST.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE ABLATION WAS PERFORMED IN THE LEFT ARTERY USING A NAVISTAR DS CATHETER DECREASE OF BLOOD PRESSURE WAS FOUND BY ECHO SYSTEM AND RECOGNIZED THAT CARDIAC TAMPONADE HAD OCCURRED. PERICARDIAL DRAINAGE WAS ATTEMPTED HOWEVER THE DOCTOR ACCIDENTALLY PUNCTURED THE LEFT ARTERY THROUGH THE RIGHT VENTRICLE WITH A PUNCTURE NEEDLE. THE BLOOD PRESSURE DID NOT RECOVER THEREFORE SURGERY WAS PERFORMED TO STOP THE BLEEDING. THE PATIENT CONDITION IS STABLE NOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NAVISTAR DS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL | OAD | BIOSENSE WEBSTER, INC (IRWINDALE) | D-1201-15-S | 13291038 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Life Threatening| O| R |