MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 16 GA X 8" (20 CM); CATHETER,INTRAVASCULAR,THERAP

Catalog Number CS-24301-E

Device Problems Difficult to Remove (1528); Material Deformation (2976)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that during insertion the guide wire feels stalled and not smooth.After hooking, it is difficult to withdraw the tube.The patient experiences pain during the procedure.

Event Description

The customer reports that during insertion the guide wire feels stalled and not smooth.After hooking, it is difficult to withdraw the tube.The patient experiences pain during the procedure.

Manufacturer Narrative

Qn#(b)(4).The customer returned various components including one guide wire assembly and introducer needle for evaluation.Visual examination revealed a slight overall curve of the wire.The distal j-tip also appeared to be deformed.The coagulated material seen in the customer supplied photo was not present, indicating that it was washed off during the decontamination process.The guide wire contained one bend 50 mm from the proximal end.The total length of the guide wire measured to be 601 mm which is within specifications of 596-604 mm per product drawing.The outer diameter of the guide wire measured to be 0.803 mm which is within specifications of 0.788-0.826 mm per product drawing.The returned guide wire was advanced through the returned introducer needle and lab inventory catheter with minimal resistance.A manual tug test confirmed both welds were fully intact.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." the customer report of a damaged guide wire was confirmed by complaint investigation of the returned sample.The guide wire passed all relevant dimensional and functional testing, and a device history record review was performed with no relevant findings.Based on the condition of the sample received, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET: 16 GA X 8" (20 CM)
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10493685
• MDR Text Key: 205689144
• Report Number: 3006425876-2020-00799
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2021
• Device Catalogue Number: CS-24301-E
• Device Lot Number: 71F20A2409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1