MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for ARROW TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE PT-65509 manufactured by Teleflex Incorporated.
[181375030]
Poor flow through right upper arm av graft. Fistulogram completed. Moderate amount of nonocclusive thrombus was noted. Percutaneous declot of fistula was attempted with arrow ptd device. Resistance was noted. Device was removed, it was noted that the tip of the arrow device was missing. The tip was retained in the distal aspect of the arterial limb per fluoroscopy. Angioplasty completed as planned. Tip of arrow left in the arterial limb as it was embedded - no further intervention required. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9769508 |
| MDR Report Key | 9769508 |
| Date Received | 2020-02-28 |
| Date of Report | 2019-12-23 |
| Date of Event | 2019-11-06 |
| Report Date | 2020-01-31 |
| Date Reported to FDA | 2020-01-31 |
| Date Reported to Mfgr | 2020-02-28 |
| Date Added to Maude | 2020-02-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE |
| Generic Name | CATHETER, EMBOLECTOMY |
| Product Code | DXE |
| Date Received | 2020-02-28 |
| Catalog Number | PT-65509 |
| Lot Number | 13F19G0001 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX INCORPORATED |
| Manufacturer Address | 3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |