MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 2-LUMEN 4 FR X 8 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	AK-25402
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "stainless guidewire coiling unravelled/bent at j-hook at tip before insertion procedure." a new swg was used from a different kit.There was no patient harm or injury.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "stainless guidewire coiling unravelled/bent at j-hook at tip before insertion procedure." a new swg was used from a different kit.There was no patient harm or injury.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided one image for analysis.The complaint of kinked guide wire was able to be confirmed by the photo.Visual analysis revealed a kink adjacent to the distal j-bend.Further comparison of the customer photo to the guide wire assembly product drawing revealed that the straightener tubes do not match.Therefore, the guide wire assembly that is pictured appears to be different than the guide wire assembly included in the kit; 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 straightener tubing shown in the product drawing does not match the straightener tubing shown in the customer image.The ifu provided with the kit informs the user, "do not use if package is damaged".Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC KIT: 2-LUMEN 4 FR X 8 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 21968038
• Report Number: 9680794-2025-00417
• Device Sequence Number: 18246370
• Product Code: FOZ
• UDI-Device Identifier: 10801902118995
• UDI-Public: (01)10801902118995(11)240807(17)260430(10)33F24G0376(21)
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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 Expiration Date: 04/30/2026
• Device Catalogue Number: AK-25402
• Device Lot Number: 33F24G0376
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2024
• 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