N
Patient 1
THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.?
MAUDE MDR 9810638
- MDR report key
- 9810638
- Report number
- 2182269-2020-00027
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-03
- Date received
- 2020-03-10
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- STEPHANIE O' SULLIVAN
- Address
- 5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US
- Phone
- 651-651-6517
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LIVEWIRE? ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2 | CATHETER, STEERABLE | ST. JUDE MEDICAL, INC. | DRA | 401575 | 401575 | 7158298 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-10 | 0 | 1. O |
Event Narratives#
D
Patient 1
DURING THE PROCEDURE, THE CATHETER BECAME ENTRAPPED IN A POSTERIOR BRANCH OF THE EYELET VEIN. DUE TO DIFFICULT DEVICE REMOVAL, THE CATHETER WAS LEFT IN THE PATIENT FOR THE REMAINDER OF THE PROCEDURE. AT THE END OF THE CASE, THE DEVICE WAS STILL STUCK SO THE DEFLECTION MECHANISM WAS CUT OFF TO ALLOW A SHEATH TO ADVANCE OVER THE CATHETER SHAFT. A DOSE OF VERAPAMIL WAS ADMINISTERED AND THE CATHETER WAS REMOVED SUCCESSFULLY. FLUOROSCOPY WAS USED WITH CONTRAST TO OBSERVE THE VEIN BUT THE VEIN WAS FUNCTIONING PROPERLY AND NO DAMAGE WAS NOTED. THE PHYSICIAN DID NOT BELIEVE THE EVENT WAS DUE TO A PERFORMANCE ISSUE WITH THE CATHETER.