MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-03 for ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET PT-65509 manufactured by Arrow International Inc..
[181829615]
(b)(4). Additional information received from sales rep. The user was not concerned about the tip migrating.
Patient Sequence No: 1, Text Type: N, H10
[181829616]
The customer reports: tip came off during use. Could not remove with snare. Used a different ptd in to loosen and they couldn't because it was embedded into the tissue. Then they put a stent over the tip. The reported defect was detected during use. The patient condition is reported as "fine". There was no patient complication, injury or consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680794-2020-00125 |
| MDR Report Key | 9781278 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-04-03 |
| Device Manufacturer Date | 2019-11-13 |
| Date Added to Maude | 2020-03-03 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| 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 | 2020-03-03 |
| Returned To Mfg | 2020-03-16 |
| Catalog Number | PT-65509 |
| Lot Number | 13F19L0282 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-03 |