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 2020-03-26 for IN.PACT AV ACCESS AVC10004008P manufactured by Medtronic Ireland.
[186747826]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186747827]
During index procedure, an in. Pact av access paclitaxel eluting balloon catheter was used to treat the left venous outflow. Approximately seven months post procedure, 70% stenosis in the central accessory vein in the avf was reported, and was treated with revascularization of the target lesion and medication. A non medtronic plain pta balloon catheter was used to treat the venous outflow. Patient recovered. Investigator and sponsor assessed event is not related to device, procedure or paclitaxel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01360 |
| MDR Report Key | 9882452 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2018-08-15 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2017-09-15 |
| Date Added to Maude | 2020-03-26 |
| 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 Country | IE |
| Manufacturer Phone | 091708734 |
| Manufacturer G1 | MEDTRONIC IRELAND |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Country | IE |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IN.PACT AV ACCESS |
| Generic Name | DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER |
| Product Code | ONU |
| Date Received | 2020-03-26 |
| Catalog Number | AVC10004008P |
| Lot Number | V07491782 |
| Device Expiration Date | 2018-06-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC IRELAND |
| Manufacturer Address | PARKMORE BUSINESS PARK WEST GALWAY IE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |