MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-17 for ACHIEVE MAPPING CATHETER - 20 MM 990063-020 manufactured by Medtronic Mexico.
[183792805]
Product event summary: the mapping catheter (b)(4) with lot number 218702917 was returned and analyzed. Visual inspection showed the introducer was removed from the shaft. The (b)(4) tubing was kinked and a twist was reviewed 0. 139 inches and 2. 75 inches from the tip. The identified malfunction was attributed to device use/operational context. In conclusion, the mapping catheter failed the returned product inspection due to the (b)(4) tubing kink and twist. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183792806]
After a completed case, the mapping catheter subsequently tested out of specification per the manufacturer's investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01198 |
| MDR Report Key | 9843679 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-10-23 |
| Date Added to Maude | 2020-03-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MEDTRONIC MEXICO |
| Manufacturer Street | AV. PASEO DEL CUCAPAH #10510 |
| Manufacturer City | TIJUANA,BC 22570 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22570 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACHIEVE MAPPING CATHETER - 20 MM |
| Generic Name | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
| Product Code | DRF |
| Date Received | 2020-03-17 |
| Returned To Mfg | 2020-02-05 |
| Model Number | 990063-020 |
| Catalog Number | 990063-020 |
| Lot Number | 218702917 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC MEXICO |
| Manufacturer Address | AV. PASEO DEL CUCAPAH #10510 TIJUANA,BC 22570 MX 22570 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |