MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW SPRING WIRE GUIDE COMPONENT; CATHETER HEMODIALYSIS IMPLANTE

Catalog Number	AW-04435
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
It was reported that: the swg was found to be kinked when removed from the pack.Another swg was used for the procedure.Prior to use, no patient involved.
Event or Problem Description
It was reported that: the swg was found to be kinked when removed from the pack.Another swg was used for the procedure.Prior to use, no patient involved.
Additional Manufacturer Narrative
Qn#(b)(4).The customer report of a kinked guide wire was confirmed by visual inspection of the customer supplied photo.The image shows a guide wire within the advancer assembly with a kink in the exposed portion of the body at the thumb guide, however, full 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 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 SPRING WIRE GUIDE COMPONENT
• Common Device Name: CATHETER HEMODIALYSIS IMPLANTE
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18226280
• Report Number: 9680794-2023-00944
• Device Sequence Number: 20384009
• Product Code: MPB
• UDI-Device Identifier: 10801902122503
• UDI-Public: 10801902122503
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K993933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2023

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: AW-04435
• Device Lot Number: 14F23B0181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2023
• 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