MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATHETER KIT: 18 GA X 16 CM; WIRE, GUIDE, CATHETER

Catalog Number	ASK-04018-UPM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn #: (b)(4).
Event or Problem Description
It was reported "the catheter has a crimp towards the end near the tip and the tip itself is crimped, would not allow wire to pass through, had to open second kit".The associated emdr report numbers are 9680794-2025-00195 and 9680794-2025-00194.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported "the catheter has a crimp towards the end near the tip and the tip itself is crimped, would not allow wire to pass through, had to open second kit".The associated emdr report numbers are 9680794-2025-00194.
Event or Problem Description
It was reported "the catheter has a crimp towards the end near the tip and the tip itself is crimped, would not allow wire to pass through, had to open second kit".The associated emdr report numbers are 9680794-2025-00195 and 9680794-2025-00194.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one arterial catheter for analysis.Signs of use were observed on the catheter body.Visual inspection of the catheter revealed two kinks towards the distal end.Visual analysis also revealed that the tip was misshapen.Microscopic examination confirmed the damage.The location of the major kinking measured 25mm and 45mm from the distal tip.The total length of the 5 7/8", which is within the specification limits of 5 13/16"-6 3/16" per the catheter product drawing.The catheter outer diameter measured 0.057", which is within the specification limits of 0.055"-0.059" per the catheter extrusion product drawing.The catheter inner diameter at the proximal end measured 0.037", which is within the specification limits of 0.037"-0.039" per the catheter extrusion product drawing.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 if package is damaged".The report of a kinked catheter was confirmed through complaint investigation of the returned sample.Visual analysis revealed a portion of the catheter body was flattened towards the distal end.R & d confirmed that the kit design likely caused or contributed to the reported damage.Based on these circumstances, the probable root cause is packaging design related.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW ARTERIAL CATHETER KIT: 18 GA X 16 CM
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21477209
• Report Number: 9680794-2025-00195
• Device Sequence Number: 3391080
• Product Code: DQX
• UDI-Device Identifier: 50801902117644
• UDI-Public: (01)50801902117644(11)241120(17)270331(10)33F24J0550(21)
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• 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,Followup
• Report Date (Section B): 02/14/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: ASK-04018-UPM
• Device Lot Number: 33F24J0550
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 04/04/2025; 05/21/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 04/09/2025; 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• 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; NOT REPORTED
• Patient Sex: Unknown