MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	CDC-45703-XPN1A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: inserter opened the package and noticed that the j tip of the wire was almost completely separated from the rest of the wire.The issue was identified prior to use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire assembly for analysis.The guide wire was returned within the advancer assembly, however, the end cap from the assembly had been removed and was not returned.Visual analysis revealed that the guide wire was kinked on the distal j-bend.This resulted in the j-bend to be slightly misshapen.During full assembly, the kink on the guide wire would have been located within the cap during packaging, shipping, and storage.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.The kink on the guide wire 591mm from the proximal weld.The guide wire total length measured 605mm, which is within the specification limits of 600mm-608mm per the guide wire product drawing.The guide wire outer diameter measure 0.80mm, which is within the specification limits of 0.788mm-0.826mm per the guide wire product drawing.The guide wire was inserted through a lab inventory arrow raulerson syringe (ars)/ introducer needle subassembly.Little to no resistance was observed as the guide wire passed completely through the subassembly.Performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".A manual tug test confirmed both welds were 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 use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed that the guide wire was kinked at the j-bend.During full assembly, the kink on the guide wire would have been located within the cap during packaging, shipping, and storage.Additionally, the guide wire passed all relevant dimensional and functional requirements.Based on these circumstances, the potential root cause cannot be determined at this time as it is unknown when the damage occurred.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: inserter opened the package and noticed that the j tip of the wire was almost completely separated from the rest of the wire.The issue was identified prior to use.There was no patient involvement.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• 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: 18864463
• Report Number: 9680794-2024-00198
• Device Sequence Number: 18202790
• Product Code: FOZ
• UDI-Device Identifier: 10801902162042
• UDI-Public: 10801902162042
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• 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): 02/12/2024

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: 09/30/2024
• Device Catalogue Number: CDC-45703-XPN1A
• Device Lot Number: 33F23G0431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2023
• 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