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 Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the set broke down when attempting to advance the actual catheter over the included wire.The whole set locked up and had to be taken out en bloc.After inspection, it appears as if the catheter itself was split from the normal distal hole and up the side of the catheter for about 5-6 mm." another catheter was used.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer provided six (6) photos and one video for analysis.The images and video show the catheter with the needle protruding through the extrusion.The reported issue of the catheter being split was confirmed.Definite signs of use were observed.The customer returned one catheter for evaluation.Visual inspection revealed dried biological material on and within the device.Three distinct areas of damage were observed , each consistent with unintentional contact with a sharp object (e.G., needle bevel) during use.Microscopic examination further confirmed the damage.The split in the catheter was located 0mm - 8.50mm from the distal end.The full length of the catheter measured 2 3/4" , which is within the specification limits of 2.715 - 2.755 per catheter product drawing.The catheter outer diameter measured 0.0441", which is within the specifications of 0.044" - 0.047" per product drawing.A long pin gauge was used to manually clear out the accumulation of biological material inside the catheter prior to functional testing.Functional testing was performed using a 22-ga lab inventory needle.The catheter was able to smoothly deploy off the needle as expected.Performed per ifu statement, "firmly hold introducer needle hub in position and advance catheter, over guidewire into vessel.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: do not reinsert needle into catheter; doing so may result in patient injury or catheter damage." the customer report of a catheter split was confirmed through complaint investigation of the returned sample.Visual inspection revealed three holes along the catheter body.The long split was located at the distal end of the catheter.The appearance of the damage is consistent with contact with the needle bevel during insertion.The catheter met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings to suggest a manufacturing issue.Based on the report, the damage was identified during use, and the appearance of the returned sample, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "the set broke down when attempting to advance the actual catheter over the included wire.The whole set locked up and had to be taken out en bloc.After inspection, it appears as if the catheter itself was split from the normal distal hole and up the side of the catheter for about 5-6 mm." another catheter was used.There was no patient harm or injury.No medical intervention required.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: 23016672
• Report Number: 9680794-2025-00753
• Device Sequence Number: 9511687
• Product Code: DQX
• UDI-Device Identifier: 00801902002730
• UDI-Public: (01)00801902002730(11)250520(17)300430(10)14F25E0036(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): 08/18/2025

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: 14F25E0036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• 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