MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-23 for IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER ADM04020013P manufactured by Medtronic Ireland.
[184431021]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184431022]
Physician intended to use an inpact admiral drug coated balloon during patient treatment. There was no damage noted to packaging prior to use. No issues noted when removing the device from the packaging. The device was inspected without issue. Ifu was followed. Negative prep performed without issue. It is reported a balloon burst occurred. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01288 |
| MDR Report Key | 9864655 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-31 |
| Date Added to Maude | 2020-03-23 |
| 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 | TONI O'DOHERTY |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Phone | 091708734 |
| Manufacturer G1 | MEDTRONIC IRELAND |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER |
| Generic Name | DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER |
| Product Code | ONU |
| Date Received | 2020-03-23 |
| Catalog Number | ADM04020013P |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC IRELAND |
| Manufacturer Address | PARKMORE BUSINESS PARK WEST GALWAY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |