MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-07 for manufactured by Cook Inc.
[116718251]
Common name & product code: unavailable as the device lot number, rpn, and gpn are unknown. Pma/510(k) number: unavailable as the device lot number, rpn, and gpn are unknown. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[116718252]
It was reported, the cook balloon catheter (product and lot numbers were not known), was splintered. This was visualized prior to use; therefore, there was no patient contact. Instead, a competitor's balloon was used to successfully complete the tibial artery percutaneous transluminal angioplasty procedure. According to the complainant, there was no patient adverse effect due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02316 |
| MDR Report Key | 7758834 |
| Date Received | 2018-08-07 |
| Date of Report | 2018-10-29 |
| Date of Event | 2018-07-24 |
| Date Mfgr Received | 2018-10-10 |
| Date Added to Maude | 2018-08-07 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Product Code | GBA |
| Date Received | 2018-08-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-07 |