MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH KIT: 20 GA X 1 1/2IN (3.81 CM); WIRE, GUIDE, CATHETER

Catalog Number	ASK-04120-HF3
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "a pa for our cardiothoracic surgery team just placed it.It broke or spliced as the pa said when she attempted to advance it.I believe this is the same issue that's been occurring." associated mdr numbers include: 9680794-2025-00728.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

• Brand Name: ARROW RA CATH KIT: 20 GA X 1 1/2IN (3.81 CM)
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22932056
• Report Number: 9680794-2025-00729
• Device Sequence Number: 10294625
• Product Code: DQX
• UDI-Device Identifier: 10801902200447
• UDI-Public: (01)10801902200447(11)250227(17)260930(10)33S24A1516(21)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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
• Report Date (Section B): 08/05/2025

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 Expiration Date: 09/30/2026
• Device Catalogue Number: ASK-04120-HF3
• Device Lot Number: 33S24A1516
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2025
• 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.
• Patient Sex: Unknown