ARROW TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE PT-65509

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for ARROW TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE PT-65509 manufactured by Teleflex Incorporated.

Event Text Entries

[181375030] Poor flow through right upper arm av graft. Fistulogram completed. Moderate amount of nonocclusive thrombus was noted. Percutaneous declot of fistula was attempted with arrow ptd device. Resistance was noted. Device was removed, it was noted that the tip of the arrow device was missing. The tip was retained in the distal aspect of the arterial limb per fluoroscopy. Angioplasty completed as planned. Tip of arrow 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

MAUDE Entry Details

Report Number	9769508
MDR Report Key	9769508
Date Received	2020-02-28
Date of Report	2019-12-23
Date of Event	2019-11-06
Report Date	2020-01-31
Date Reported to FDA	2020-01-31
Date Reported to Mfgr	2020-02-28
Date Added to Maude	2020-02-28
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
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
Single Use	3
Previous Use Code	3
Event Type	3
Type of Report	3

Device Details

Brand Name	ARROW TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE
Generic Name	CATHETER, EMBOLECTOMY
Product Code	DXE
Date Received	2020-02-28
Catalog Number	PT-65509
Lot Number	13F19G0001
Device Availability	N
Device Eval'ed by Mfgr	*
Device Sequence No	1
Device Event Key	0
Manufacturer	TELEFLEX INCORPORATED
Manufacturer Address	3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US 27560

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-28