MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH. SET: 20 GA X 8CM; CATHETER PERCUTANEOUS

Model Number IPN037640

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 06/03/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

Customer complaint reports "the catheter gets blocked quickly, within 48 hours.So we can't performed blood sample then.And we have to replace the catheter quicker than previously.It was reported the patient had a bilateral radial artery thrombosis following a catheter insertion.Patient had a right radial catheter that was "dysfunctional" 1 day after insertion (captured in 3006425876-2021-00655) and was replaced with catheter in left radial site.Clinician performed seal test, flushing, rinsing the device with a syringe and checking the back pressure on the line.Device ultimately replaced with new catheter.Customer concerned with risk for vascular injury and reports "it can be considered that the repeated aggression of the vascular endothelium by an intravascular device leads to an increase in the risk of thrombosis and can be involved in a thrombosis occurrence.".

Event Description

Customer complaint reports "the catheter gets blocked quickly, within 48 hours.So we can't performed blood sample then.And we have to replace the catheter quicker than previously.".It was reported the patient had a bilateral radial artery thrombosis following a catheter insertion.Patient had a right radial catheter that was "dysfunctional" 1 day after insertion (captured in 3006425876-2021-00655) and was replaced with catheter in left radial site.Clinician performed seal test, flushing, rinsing the device with a syringe and checking the back pressure on the line.Device ultimately replaced with new catheter.Customer concerned with risk for vascular injury and reports "it can be considered that the repeated aggression of the vascular endothelium by an intravascular device leads to an increase in the risk of thrombosis and can be involved in a thrombosis occurrence.".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: section g.2.-report source corrected.

• Brand Name: ARROW ARTERIAL CATH. SET: 20 GA X 8CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12205588
• MDR Text Key: 262953880
• Report Number: 3006425876-2021-00663
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K093050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN037640
• Device Catalogue Number: SAC-00820-PBX
• Device Lot Number: 71F21B0599
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 07/21/2021
• Supplement Dates Manufacturer Received: 08/24/2021
• Supplement Dates FDA Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED