MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN/PSI SET; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	SI-11142
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: during the procdeure according to ifu, md found that guide wire bent and kinked.So md opend up the new kit to finish the procedure.There was no reported patient harm or consequence.
Event or Problem Description
It was reported that: during the procedure according to ifu, md found that guide wire bent and kinked.So md opened up the new kit to finish the procedure.There was no reported patient harm or consequence.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned multiple components of a psi kit, including one guide wire assembly, arrow raulerson syringe (ars), and dilator, for analysis.No definite signs of use were observed.Visual analysis revealed that the guide wire contained one major kink towards the distal end.The distal j-bend appeared intact.Microscopic examination confirmed the kink.The distal and proximal welds were present and were observed to be full and spherical.The kink in the guide wire was located 410 mm from the proximal tip.The overall length of the guide wire measured 455mm which is within the specification of 450-458mm per product drawing.The outer diameter of the guide wire measured 0.849mm which is within the specification of 0.838-0.877mm per guide wire product drawing.Functional inspection of the guide wire was performed per the instructions for use (ifu) provided with the kit which states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was able to pass through the returned arrow raulerson syringe (ars)/18 ga introducer needle subassembly with no resistance.A manual tug test confirmed the distal and proximal welds were intact.A device history record review was performed on the guide wire with no relevant findings.The ifu provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire.The report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire was kinked in multiple locations towards the distal end.The returned guide wire met all relevant dimensional requirements and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW MULTILUMEN/PSI SET
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18423958
• Report Number: 3006425876-2024-00001
• Device Sequence Number: 20757411
• Product Code: FOZ
• UDI-Device Identifier: 00801902102898
• UDI-Public: 00801902102898
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K002507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

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 Expiration Date: 03/28/2026
• Device Catalogue Number: SI-11142
• Device Lot Number: 71F22F3158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown