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 2020-03-19 for IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER ADM05025013P manufactured by Medtronic Ireland.
[184172348]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184172349]
Physician intended to use an inpact admiral during treatment of the patient? S proximal superficial femoral artery (sfa). No vessel tortuosity or calcification are reported. Ifu was followed. Pre-dilation was not performed. The device was passed through a previously deployed stent and resistance was encountered. No excessive force was used. It is reported a balloon burst occurred at an inflation pressure of 11 atm on first inflation. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01230 |
| MDR Report Key | 9852873 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-13 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2018-11-05 |
| Date Added to Maude | 2020-03-19 |
| 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 | 2020-03-19 |
| Model Number | ADM05025013P |
| Catalog Number | ADM05025013P |
| Lot Number | 0009417409 |
| 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 | 2020-03-19 |