MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-22703-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: during the procedure according to ifu, md found the guide wire to be bent.So md open up the new kit to finish the procedure.There was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4) the customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.The customer returned one opened cvc set with multiple components, including one guide wire in its advancer tube, and one arrow raulerson syringe (ars) for evaluation.Signs-of-use were observed on the returned components.Visual inspection of the guide wire revealed several kinks and bends throughout the body.The distal j-bend was misshapen but intact.Microscopic examination confirmed the damage.Both welds were present and observed to be full and spherical.The major kinks in the guide wire measured 47mm and 66mm via calibrated ruler from the distal end.The guide wire length measured 458mm via calibrated ruler which was within the specifications of 450-458mm per product drawing.The guide wire outer diameter (od) measured 0.80mm via calibrated caliper which was within the specifications of 0.788-0.826mm per product drawing.Functional inspection of the guide wire was performed per the instructions-for-use (ifu) provided with the kit which states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was threaded through the returned ars and a lab inventory introducer needle.The undamaged portions of the guide wire were able to pass with no resistance.A manual tug test confirmed the distal and proximal welds were intact.The instructions-for-use (ifu) provided with the kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained, and further consultation requested." a device history record review was performed with no relevant findings.Based on these circumstances, 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 that: during the procdeure according to ifu, md found the guide wire to be bent.So md opend up the new kit to finish the procedure.There was no reported ptient harm or consequence.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 16 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18533264
• Report Number: 3006425876-2024-00077
• Device Sequence Number: 17778317
• Product Code: FOZ
• UDI-Device Identifier: 00801902102218
• UDI-Public: 00801902102218
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K900263
• 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): 12/26/2023

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: 02/23/2024
• Device Catalogue Number: CS-22703-E
• Device Lot Number: 71F22C0475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2022
• 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