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	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "during the procedure according to ifu, the md found a guide wire bend.So the md opened up the new kit to finish the procedure." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one opened psi kit including multiple components.The guide wire will be analyzed as part of this investigation.No definite signs of use were observed.Visual analysis revealed that the guide wire contained one kink towards the distal end.The distal j-bend is slightly misshapen.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 were located 432mm from the proximal tip.The overall length of the guide wire measured 456mm, which is within the specification of 450-458mm per product drawing.The outer diameter of the guide wire measured 0.860mm 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 encountered resistance when the kink passed through the introducer needle.All undamaged sections of the guide wire were able to pass through the arrow raulerson syringe (ars)/ 18 ga introducer needle subassembly with no resistance.A manual tug test confirmed the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire".The ifu also states, "do not apply excessive force in placing or removing guidewire, dilator, or access device.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested".The report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire was kinked towards the proximal end.The guidewire met all relevant dimensional requirements.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.
Event or Problem Description
It was reported "during the procedure according to ifu, the md found a guide wire bend.So the md opened up the new kit to finish the procedure." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• 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 DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21838742
• Report Number: 9680794-2025-00334
• Device Sequence Number: 7963691
• Product Code: FOZ
• UDI-Device Identifier: 00801902102898
• UDI-Public: (01)00801902102898(11)240731(17)280928(10)71F24G0395(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K002507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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 Catalogue Number: SI-11142
• Device Lot Number: 71F24G0395
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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