MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2020-03-18 for ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET PT-65509 manufactured by Arrow International Inc..
[184071005]
Qn#: (b)(4). Customer contacted regarding this event and reports: there was no negative impact to the patient. No intervention required. No patient injury or complication. The tip was retained in the patient without incident.
Patient Sequence No: 1, Text Type: N, H10
[184071006]
According to the medwatch (2401060000-2019-8007) "poor flow through right upper arm av graft. Fistulogram completed. Moderate amount of nonocclusive thrombus was noted. Percutaneous declot of fistula was attempted with ptd device. Resistance was noted. Device was removed, it was noted that the tip of the device was missing. The tip was retained in the distal aspect of the arterial limb per fluoroscopy. Angioplasty completed as planned. Tip of device 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 | 9680794-2020-00148 |
| MDR Report Key | 9849379 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-06 |
| Date of Event | 2019-11-06 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-07-01 |
| Date Added to Maude | 2020-03-18 |
| 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 | RISK MANAGER |
| 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 | 2020-03-18 |
| Catalog Number | PT-65509 |
| Lot Number | 13F19G0001 |
| Device Availability | N |
| 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 | 2020-03-18 |