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 2020-03-03 for ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT PT-65509-HFC manufactured by Arrow International Inc..
[181763919]
(b)(4). Additional information received from the doctor at the user facility. Patient with small hematoma. Attempted retrieval but tip in small vein branch and couldn't be retrieved. Tip left in , so no further harm caused.
Patient Sequence No: 1, Text Type: N, H10
[181763920]
The customer reports that the tip of the ptd thrombectomy device broke off and became lodged within the soft tissue just below the elbow. Attempts to remove it were unsuccessful due to its extravascular location.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680794-2020-00109 |
| MDR Report Key | 9780052 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 2019-11-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 KIT |
| Generic Name | CATHETER, EMBOLECTOMY |
| Product Code | DXE |
| Date Received | 2020-03-03 |
| Catalog Number | PT-65509-HFC |
| Lot Number | 13F19L0323 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-03 |