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 ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET PT-65509 manufactured by Arrow International Inc..
[185251927]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185251928]
Physician was pulling the device back through clot toward the sheath while activating the device. It snagged on the distal end of a stent and the tip broke off. The tip then travelled centrally and stopped near the proximal end of the stent and stopped near the axilla. Physician attempted to snare the retained tip out of the patient but was unsuccessful. Therapy was interrupted/delayed due to attempting to snare device fragment out. Patient is ultimately fine, no injury sustained. Device fragment was embedded in vessel wall with angioplasty balloon and remained stable for remainder of procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680794-2020-00173 |
| MDR Report Key | 9883517 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-20 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2020-01-14 |
| 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 | MARGIE BURTON, RN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | ARROW INTERNATIONAL DE MEXICO S.A. DE C.V. |
| Manufacturer Street | AVE. WASHINGTON 3701 COLONIA PANAMERICANA, CHIHUAHUA |
| Manufacturer City | CHIHUAHUA 31200 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 31200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET |
| Generic Name | CATHETER EMBOLECTOMY |
| Product Code | DXE |
| Date Received | 2020-03-26 |
| Catalog Number | PT-65509 |
| Lot Number | 13F20A0286 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC. |
| Manufacturer Address | READING PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |