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	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "wire broken" prior to use.No patient involvement was reported.
Additional Manufacturer Narrative
(b)(4).The report of a kinked guide wire was confirmed through complaint investigation of the returned sample.The customer returned one guide wire assembly for analysis.Signs-of-use were observed on the guide wire and inside the guide wire tubing, which contradicts the customer report that the defect was observed prior to use.The customer was contacted as part of this discrepancy, and they stated that the sample was handled with bloody gloves; however, they cannot 100% confirm.Visual analysis revealed that the guide wire was kinked due to offset coils at 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 599mm from the proximal weld.The guide wire total length measured 606mm, which was within the specification limits of 600mm-608mm per the guide wire product drawing.The kink and the guidewire total length were measured via calibrated ruler.The guide wire outer diameter measured 0.790mm via calibrated caliper, which was within the specification limits of 0.788mm-0.826mm per the guide wire product drawing.The functional inspection was performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".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.A manual tug test confirmed both welds were intact.Feedback from the purchasing facility indicated that the damage could have occurred during the supplier manufacturing or during storage/handling of the assembly.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".A device history record review was performed, and no relevant findings were identified.The root cause of the issue was undetermined at this time and further investigations were initiated to further analyse this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "wire broken" prior to use.No patient involvement was reported.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17999003
• Report Number: 9680794-2023-00874
• Device Sequence Number: 5830995
• Product Code: FOZ
• UDI-Device Identifier: 10801902162042
• UDI-Public: 10801902162042
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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: 09/30/2024
• Device Catalogue Number: CDC-45703-XPN1A
• Device Lot Number: 33F23D0949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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
• Patient Sex: Unknown