FDA Adverse Event
Other
Summary report: N
PATHFINDER 8,2-6-2,135
MDR report key: 187217
·
Received September 9, 1998
Report
- Report Number
- 2951009-1998-00001
- Event Type
- Other
- Date Received
- September 9, 1998
- Report Date
- August 7, 1998
- Manufacturer
- CARDIMA, INC.
- Product Code
- DRF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
FAX RECEIVED FROM JAPANESE DISTRIBUTER, 8/7/98: "IT SEEMS THAT THE COIL CAME LOOSE DUE TO ONE OF ACTIONS TAKEN BY THE DOCTOR. 1. AFTER RECORDING SIGNALS FROM THE PATHFINDER, THE DOCTOR PULLED ON THE CATHETER TO REMOVE IT AND ENCOUNTERED A BIT OF RESISTANCE. 2. NEXT HE ATTEMPTED TO REINSERT THE CATHETER THE FEW MILIMETERS THAT HE HAD JUST WITHDRAWN IT. WHILE REINSERTING THE CATHETER HE TORQUED THE CATHETER TO HELP IT TO FREE FROM WHATEVER IT WAS CAUGHT ON."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PATHFINDER 8,2-6-2,135 | PATHFINDER | DRF | CARDIMA, INC. | * | M0703 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |