FDA Adverse Event
Injury
Summary report: N
NAVISTAR/CELSIUS THERMO-COOL DIAGNOSTIC/ABLATION DEFLECTABLE CATHETER
MDR report key: 1031593
·
Received March 19, 2008
Report
- Report Number
- 2029046-2008-00008
- Event Type
- Injury
- Date Received
- March 19, 2008
- Date of Event
- February 25, 2008
- Report Date
- February 27, 2008
- Manufacturer
- BIOSENSE WEBSTER, INC. (IRWINDALE)
- Product Code
- DRF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION, AS IT WAS DISCARDED BY THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A BLEED AFTER A PROCEDURE AND THEN CODED AFTER THE BLEED. CUSTOMER STATED, THERE WERE 4 CATHETERS IN THE PATIENT DURING THE PROCEDURE: A CS CATHETER, A NAVISTAR F CURVE, AN ACCUSON 8 FRENCH, AND A QUAD. CUSTOMER ALSO STATED, THAT THE CATALOG NUMBERS AND LOT NUMBERS OF THE CATHETERS WERE UNKNOWN. SUBSEQUENT FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE COMPLAINT PRODUCT HAD BEEN DISCARDED. THE CUSTOMER ALSO INDICATED THAT THE PATIENT WAS EXPECTED TO FULLY RECOVER FROM THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NAVISTAR/CELSIUS THERMO-COOL DIAGNOSTIC/ABLATION DEFLECTABLE CATHETER | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL | DRF | BIOSENSE WEBSTER, INC. (IRWINDALE) | NAVISTAR THERMO TC | UNK NAVISTAR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Life Threatening | QUAD| ACCUSON 8 FRENCH| CS CATHETER |