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

Catalog Number	ASK-04020-MAR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "a physician attempted to place this product inside a patient, and as you can see from pic 1, a piece broke off." additional information was requested from the customer; however, further details have not been provided at this time.
Additional Manufacturer Narrative
(b)(4) the actual device was not returned; however, the customer provided three photos for analysis.The complaint of an unraveled guide wire was able to be confirmed by the photo.The image shows a guidewire with evidence of unraveling; however, a complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were 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 customer report of an unraveled guide wire was confirmed by visual inspection of the customer supplied photos.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force when tested per iso 11070 test configuration.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.Based on these circumstances, unintentional use error likely contributed to this event; however, the probable cause cannot be determined without the device returned for analysis.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "a physician attempted to place this product inside a patient, and as you can see from pic 1, a piece broke off." additional information was requested from the customer; however, further details have not been provided at this time.

• Brand Name: ARROW RA CATH KIT: 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: 23596291
• Report Number: 9680794-2025-00953
• Device Sequence Number: 18470812
• Product Code: DQX
• UDI-Device Identifier: 10801902159776
• UDI-Public: (01)10801902159776(11)250703(17)270930(10)33F25E0979(21)
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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-04020-MAR
• Device Lot Number: 33F25E0979
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2025
• 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