MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH SET: 20 GA X 1-3/4IN; WIRE GUIDE CATHETER

Catalog Number	RA-04020
Medical Device Problem Codes	Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "radial arterial art line insertion.Catheter in artery as per ultrasound guide.Guide wire threaded through catheter easily.Upon catheter insertion over guide wire, resistance felt.Catheter pulled back and guide wire pulled back.Guide wire floated into vessel on its own.At this point, both catheter and guide wire removed from patient.Guide wire "coating" was severed.X ray done and vascular service contacted for further management.Xray showed no guide wire in patient".Surgery was delayed for 45 minutes.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4).The customer returned one arterial catheterization device.The catheter appeared to be advanced off the catheterization device and was not returned for analysis.Signs of use in the form of biological material were observed on the guidewire and inside the guide wire tubing.Visual analysis revealed that the guidewire exited the needle bevel; however, the black guide wire handle was located on the proximal end of the tubing.This indicates that the guide wire handle was advanced then retracted.Further analysis revealed that the section of guide wire exiting the needle bevel was severely unraveled.Microscopic examination confirmed the unraveling and revealed that the core wire separated directly adjacent to the distal weld.Visual analysis could not be performed on the catheter as it was not returned for analysis.The guide wire outer diameter (in a section located within the guide wire tubing) measured 0.4445mm, which is within the specification limits of 0.432mm-0.457mm per the guide wire product drawing.The guide wire length could not be accurately measured as the core wire was lodged inside the needle cannula.Similarly, the inner diameter of the needle cannula could not be measured.Functional inspection could not be performed on the guidewire due to the severity of the damage.A device history record review was performed, and one relevant finding was identified.The ifu provided with the kit informs the user, "to reduce the risk of guidewire damage, do not retract guidewire against edge of needle while in vessel".The ifu also states, "if resistance is encountered during guidewire advancement do not force feed, withdraw entire unit and attempt new puncture".The ifu also states, "do not reinsert needle into catheter; doing so may result in patient injury or catheter damage".The report of an unraveled guide wire was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the guide wire was deployed through the needle bevel and was unraveled.The customer reported that after encountering resistance, the "catheter pulled back and guide wire pulled back".The ifu provided with the kit clearly states, "to reduce the risk of guidewire damage, do not retract guidewire against edge of needle while in vessel".A device history record review was performed, and no relevant manufacturing issues were identified.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.0 pounds force.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Despite the catheter not being returned for analysis, consideration of the customer report and the damage observed on the returned sample , unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "radial arterial art line insertion.Catheter in artery as per ultrasound guide.Guide wire threaded through catheter easily.Upon catheter insertion over guide wire, resistance felt.Catheter pulled back and guide wire pulled back.Guide wire floated into vessel on its own.At this point, both catheter and guide wire removed from patient.Guide wire "coating" was severed.X ray done and vascular service contacted for further management.Xray showed no guide wire in patient".Surgery was delayed for 45 minutes.The patient's current condition is reported as "unknown".

• Brand Name: ARROW RA CATH SET: 20 GA X 1-3/4IN
• 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: 22771449
• Report Number: 9680794-2025-00673
• Device Sequence Number: 13201599
• Product Code: DQX
• UDI-Device Identifier: 00801902002730
• UDI-Public: (01)00801902002730(11)250326(17)300228(10)14F25C0118(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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-04020
• Device Lot Number: 14F25C0118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2025
• 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