MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARTERIAL CATH SET:20 GA CATH/22 GA NDL; WIRE GUIDE CATHETER

Catalog Number	FA-04020
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: guidewire won't pass through the needle.Additional information: there was a delay in the procedure but there was no other reported patient harm or consequence from the incident.The wire was returned for investigation and the engineers noted that it was kinked.
Event or Problem Description
It was reported that: guidewire won't pass through the needle.Additional information: there was a delay in the procedure but there was no other reported patient harm or consequence from the incident.The wire was returned for investigation and the engineers noted that it was kinked.
Additional Manufacturer Narrative
(b)(4).The customer report of guide wire/needle resistance was confirmed through complaint investigation of the returned sample.The customer returned one opened arterial catheterization kit for analysis.Signs-of-use were observed inside the returned device.Visual inspection of the guide wire revealed offset coils towards the distal end.Microscopic examination confirmed the damage.The distal weld was present and appeared full and spherical.In addition, a white substance resembling adhesive was observed on the surface of the guide wire.The guide wire offset coils were located 1-2mm via calibrated ruler from the distal end.The guide wire length from the handle to the distal end measured 9 1/2" via calibrated ruler which was within the specifications of 9 1/4"-9 1/2" per product drawing.The guide wire outer diameter (od) measured 0.45mm via calibrated caliper which was within the specifications of 0.432-0.457mm per product drawing.Functional inspection was performed on the returned device based on the instructions-for-use (ifu) provided with the kit which states, "remove guard.Trial advance and retract guidewire through needle using guidewire handle to ensure proper function." a lab inventory guide wire was attempted to be threaded through the cannula.Resistance was observed when threading the lab inventory guide wire.The instructions-for-use (ifu) provided with the kit warns the user, "precaution: if resistance is encountered during guidewire advancement do not force feed, withdraw entire unit and attempt new puncture." a device history record review was performed, and no relevant findings were identified.Based on the observed failure mode and the comments from manufacturing, the probable root cause was likely manufacturing related.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARTERIAL CATH SET:20 GA CATH/22 GA NDL
• Common Device Name: WIRE GUIDE CATHETER
• 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: 18622011
• Report Number: 9680794-2024-00104
• Device Sequence Number: 14055044
• Product Code: DQX
• UDI-Device Identifier: 00801902100603
• UDI-Public: 00801902100603
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K810675
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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 Catalogue Number: FA-04020
• Device Lot Number: 13F22F0071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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: Male