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	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during the product preparation/pre-test prior to the procedure, it was found that the the guidewire was kinked/twisted.It was replaced with a new product." there was no patient involvement.
Additional Manufacturer Narrative
(b)(4).The customer returned one open arterial kit for analysis.Visual analysis revealed that the guidewire was kinked within the tubing and could not be advanced through the needle cannula.Additionally, kinking and offset coils were observed on the unexposed portion of the guidewire.Microscopic examination confirmed the presence of damage.The distal end of the guidewire had completely retracted into the tubing , where it became lodged.As a result of this damage, the guidewire could not be deployed.The kinking on the guidewire measured 0mm - 24mm from the distal tip.The guidewire total length from the handle to the distal tip measured 4 9/16", which is within the specification limits of 4 7/16" - 4 11/16" per the guidewire with handle product drawing.The guidewire outer diameter measured 0.38mm, which is within the specification limits of 0.381mm - 0.404mm per the guide wire product drawing.The cannula outer diameter measured 0.0250" , which is within the specification limits of 0.0250" - 0.0255" per the cannula product drawing.The cannula inner diameter measured 0.017", which is within the specification limits of 0.0165" - 0.0180" per the cannula product drawing.An attempt to insert the guidewire into the needle cannula was performed; however, this was unsuccessful due to the damage to the guidewire.Therefore, functional testing could not be performed without the risk of damaging the sample.A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "if resistance is encountered during guidewire advancement, do not force feed, withdraw entire unit and attempt new puncture".The report of a kinked and twisted guidewire was confirmed through investigation of the returned sample.Visual analysis revealed that the guidewire was kinked within the tubing and could not be advanced through the needle cannula.Additionally, offset coils were observed, which is likely the result of retracting the guidewire against the needle bevel.Finished good ra-04122 consists of two components - guide wire tube (a-04122-006a) and catheter/needle (a-04122-012) - which are assembled by the user via insertion of the hub adapter into the needle hub.Evidence of material flash was observed in the connector hub component which could contribute to the resistance reported by the customer.The potential of mispositioning of the guide wire during assembly and the flash within the adapter will need to be further investigated at the manufacturing facility.Based on these circumstances, it was determined that manufacturing likely caused or contributed to the reported event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that "during the product preparation/pre-test prior to the procedure, it was found that the the guidewire was kinked/twisted.It was replaced with a new product." 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: 23401799
• Report Number: 9680794-2025-00875
• Device Sequence Number: 9945655
• Product Code: DQX
• UDI-Device Identifier: 00801902002754
• UDI-Public: (01)00801902002754(11)241028(17)290930(10)14F24K0378(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): 10/02/2025

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: 14F24K0378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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
• Patient Sex: Unknown