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 2020-03-19 for ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT PT-65509-HFC manufactured by Arrow International Inc..
[184149644]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184149645]
The customer reports: performing a declot fistulagram with 5fr treretola in ir lab. After multiple attempts to break up the clot it was discovered that part of the radiopaque tip at the end of the trerotola basket had broken off. The user didn't see it on our sterile field so looked at chest and hand with fluoroscopy and didn't see the tip in either place. The patient was discharged later in the day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680794-2020-00147 |
| MDR Report Key | 9853516 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-08-19 |
| Date Added to Maude | 2020-03-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 KIT |
| Generic Name | CATHETER, EMBOLECTOMY |
| Product Code | DXE |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-13 |
| Catalog Number | PT-65509-HFC |
| Lot Number | 13F19H0347 |
| Device Availability | R |
| 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 | 2020-03-19 |