MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-45854-E
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: during the installation of the device, when trying to remove the guide with the catheter already inserted, the guide presents resistance to removal, so the complete removal of the catheter + guide device is carried out.Once outside, it is found that the guide is bent.
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer report of guide wire/catheter resistance was confirmed by visual inspection of the customer supplied video and photo.The video shows a guide wire advanced through a catheter in a clinical setting (not in use on patient).Resistance can be observed in the video while removing the guide wire from the catheter, 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.
Event or Problem Description
It was reported that: during the installation of the device, when trying to remove the guide with the catheter already inserted, the guide presents resistance to removal, so the complete removal of the catheter + guide device is carried out.Once outside, it is found that the guide is bent.
Additional Manufacturer Narrative
(b)(4).Udi related data quality updates only: section d.4.- unique identifier (udi) # corrected to (b)(4).
Event or Problem Description
It was reported that: during the installation of the device, when trying to remove the guide with the catheter already inserted, the guide presents resistance to removal, so the complete removal of the catheter + guide device is carried out.Once outside, it is found that the guide is bent.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18226160
• Report Number: 3006425876-2023-01148
• Device Sequence Number: 5557118
• Product Code: FOZ
• UDI-Device Identifier: 00801902102423
• UDI-Public: (01)00801902102423(11)230213(17)250103(10)71F23B1142(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K993691
• 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,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 Expiration Date: 01/03/2025
• Device Catalogue Number: CS-45854-E
• Device Lot Number: 71F23B1142
• Was Device Available for Evaluation?: No
• 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; Not provided
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/18/2023; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2023
• 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; NOT REPORTED
• Patient Sex: Unknown