MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH SET: 22 GA X 1-3/8IN; WIRE GUIDE CATHETER

Catalog Number	RA-04122
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "during the product preparation prior to the a-line procedure, a product defect was found - the tip of the catheter was bent.A new product from another supplier was used for the procedure." additional information received clarifies the guidewire was kinked.There was no patient involvement.
Additional Manufacturer Narrative
Qn# (b)(4).The customer provided three photos for analysis.The customer also returned one arterial catheterization assembly for analysis.The guide wire tube and the catheter/needle assembly were assembled upon return.No obvious signs of use in the form of biological material were observed on the device which matches the customer report the defect was found during product preparation prior to the procedure.Visual and microscopic analysis revealed the guide wire was curled towards the distal end, and there was a kink towards the proximal end.Both the curl and the kink exposed the guide wire outside of the guide wire tube.The distal weld was full and spherical.Microscopic examination revealed the coil wires appeared compressed against each other and there was one coil that was unraveled over the distal weld.The coil wire remained intact to the weld.No signs of adhesive nor other defects or anomalies were observed on the device.The outer diameter of the guide wire measured 0.381 mm, which is within the specification limits of 0.381-0.404 mm per guide wire product drawing.The inner diameter of the needle cannula measured 0.017", which is within the specification limits of 0.0165"-0.0180" per needle cannula product drawing.Functional testing could not be performed due to the nature of the damage to the guide wire.A manual tug test confirmed the core wire was intact to the weld.Manufacturing and r & d were contacted as a part of this complaint investigation.Manufacturing stated it is unlikely that the defect would have occurred during the manufacturing process as there is a 100% inspection for each device.The coils for guide wires are manufactured to a certain length prior to assembly to the core wire.Excess coil wire length would not allow the coil and core wire to be welded together.R & d stated the degree of damage observed on the guide wire is likely due to significant excessive force used during trial advancement of the guide wire.Finished good ra-04122 is sold in two components: the guide wire tube and the catheter/needle component, which is to be assembled by the user by inserting the hub adapter to the cannula hub.If the guide wire is not returned to its original position prior to assembly, the guide wire can be damaged against the hub adapter.The device was returned assembled, which suggests the likely occurred during user assembly.This matches the customer report the defect was found during product preparation prior to the procedure.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "precaution: if resistance is encountered during guidewire advancement do not force feed, withdraw entire unit and attempt new puncture.".The customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.The guide wire was curled towards the distal end, and there was a kink towards the proximal end.Finished good ra-04122 consists of two components - guide wire tube and catheter/needle - which are assembled by the user via insertion of the hub adapter into the cannula hub.Improper repositioning of the guide wire prior to assembly can result in damage against the hub adapter.The device was returned assembled, suggesting the damage likely occurred during user assembly.The kink and curl suggest the guide wire was damaged during device preparation, with subsequent advancement attempts causing the guide wire to protrude from the tubing.However, the coil unraveling over the distal weld is an atypical, previously unobserved defect.Manufacturing confirmed this is not a manufacturing error, and there is no indication that the coil wire snagged on the cannula opening.A device history record review revealed no relevant findings.Based on these circumstances, the root cause of the defect remains undetermined.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that "during the product preparation prior to the a-line procedure, a product defect was found.The tip of the catheter was bent.A new product from another supplier was used for the procedure.".Additional information received clarifies the guidewire was kinked.There was no patient involvement.

• Brand Name: ARROW RA CATH SET: 22 GA X 1-3/8IN
• 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: 22773147
• Report Number: 9680794-2025-00716
• Device Sequence Number: 21123758
• Product Code: DQX
• UDI-Device Identifier: 00801902002754
• UDI-Public: (01)00801902002754(11)240914(17)290831(10)14F24J0038(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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: RA-04122
• Device Lot Number: 14F24J0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2024
• 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