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	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "arterial line broke inside patient.Incision made to remove and was successful.The patient's current condition is unknown at this time.
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened arterial catheterization kit for analysis.Signs of use in the form of excess biological material were observed on and within the device.Visual analysis revealed the guide wire was completely deployed through the needle cannula and was unraveled towards the distal end.Microscopic examination of the guide wire confirmed the core wire was separated approximately 2cm from the distal weld.The distal weld was full and spherical.It was also noted that the catheter was separated.The separated portion was partially deployed off the needle cannula and was crimped over the unraveled guide wire.Excess biological material was observed between the catheter and the needle cannula.No signs of adhesive nor other defects or manufacturing anomalies were observed on the device.The guide wire length from the handle to the distal weld (added separated portion of the core wire) measured 4 9/16", which is within the specification limits of 4 7/16"-4 11/16" per the guide wire with handle product drawing.The guide wire outer diameter measured 0.381mm (0.015"), which is within the specification limits of 0.381-0.404 mm per guide wire product drawing.To accurately measure the catheter, the entire catheter body was deployed off the cannula and guide wire.The total catheter body length (per measurement b in the catheter over needle product drawing) measured 2.4375", which is within the specification limits of 2.4300"-2.4450".The catheter body inner diameter (at the point of separation) measured 0.028", which is within the specification limits of 0.027"-0.029" per catheter extrusion product drawing.The catheter outer diameter measured 0.0355", which is within the specification limits of 0.0350"-0.0370" per the catheter extrusion product drawing.Functional testing could not be performed due to the nature of the damage on the guide wire and catheter.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit warns the user, "precaution: do not reinsert needle into catheter; doing so may result in patient injury or catheter damage".The ifu also states, "to reduce the risk of guidewire damage, do not retract guidewire against edge of needle while in vessel".The report of guide wire and catheter resistance with an unraveled guide wire was confirmed through complaint investigation of the returned sample.Visual analysis revealed the guide wire was unraveled towards the distal end and excess biological material was observed on and within the device.It was noted that the catheter body was also severed and showed evidence of crimping on the guide wire.The condition of the sample received suggests 1) unintentional undue force applied resulting in the guide wire unraveling, 2) this unraveling in combination with the biological material resulted in the resistance encountered, and 3) the catheter was retracted against the needle bevel resulting in the separation.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 1.5 pounds force.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire damage.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional user error likely caused or contributed to the reported event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "arterial line broke inside patient.Incision made to remove and was successful.The patient's current condition is unknown at this time.

• 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: 22883328
• Report Number: 9680794-2025-00722
• Device Sequence Number: 9604795
• Product Code: DQX
• UDI-Device Identifier: 00801902002754
• UDI-Public: (01)00801902002754(11)230215(17)280131(10)14F23B0032(21)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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: 14F23B0032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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