FDA Adverse Event
Malfunction
Summary report: N
ACHIEVE MAPPING CATHETER - 20 MM
MDR report key: 8712152
·
Received June 19, 2019
Report
- Report Number
- 9612164-2019-02423
- Event Type
- Malfunction
- Date Received
- June 19, 2019
- Date of Event
- March 26, 2019
- Report Date
- June 19, 2019
- Manufacturer
- MEDTRONIC MEXICO
- Product Code
- DRF
- PMA / PMN Number
- K102588
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE MAPPING CATHETER 990063-020 WITH LOT 216772233 WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE RETURNED CATHETER SHOWED THE SHAFT OF THE CATHETER WAS KINKED. IN CONCLUSION, THE MAPPING CATHETER 990063-020 WITH LOT 216772233 FAILED THE RETURNED PRODUCT INSPECTION DUE TO A SHAFT KINK. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
AFTER A COMPLETED CASE, THE MAPPING CATHETER SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 507003 | ACHIEVE MAPPING CATHETER - 20 MM | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | DRF | MEDTRONIC MEXICO | 990063-020 | 216772233 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |