MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CV-47702-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the swg was found kinked prior to the patient.They changed a new one." no patient involvement therefore no patient harm or injury.
Event or Problem Description
It was reported "the swg was found kinked prior to the patient.They changed a new one." no patient involvement therefore no patient harm or injury.
Additional Manufacturer Narrative
(b)(4).The customer returned one opened cvc kit, including one guide wire assembly, 2-l catheter, and arrow raulerson syringe (ars) for evaluation.The end cap and straightener tubing, which are components of the guide wire assembly, were returned but not attached to the assembly.No definite signs of use were observed.Visual analysis revealed that the guide wire contained one kink on the distal j-bend.Microscopic examination confirmed the damage.The guide wire end cap and straightener tubing were reassembled to the assembly, and it was observed that the kink would be protected within the end cap during packaging, shipping, and storage.Both welds were observed to be full and spherical.No other defects or anomalies were observed with the guide wire, tubing , nor the returned tray.The kink in the guide wire measured 7mm form the distal end.The overall length of the guide wire measured 598mm, which is within the specifications of 596-604mm per product drawing.The guide wire outer diameter measured 0.803mm, which is within the specifications of 0.788-0.826mm per product drawing.The guide wire was functionally tested using a lab inventory arrow raulerson syringe (ars)/18 ga introducer needle subassembly based on 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." slight resistance was observed at the kinked portion of the guide wire, however, the undamaged portions of the guide wire were able to pass through both components with no resistance.A manual tug test confirmed both welds were intact.A device history record review was performed , and no relevant findings were identified.The 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." the report of a kinked guide wire was confirmed through examination of the returned sample.One kink was observed on the distal end of the guide wire body.The guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.During normal assembly, the kinked portion of the guidewire is protected within the end cap of the advancer assembly , however, the end cap and straightener tubing were not returned assembled to the tubing.Based on the customer report and sample received, the potential root cannot be determined as it cannot be confirmed when the damage occurred.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19219843
• Report Number: 3006425876-2024-00379
• Device Sequence Number: 8106009
• Product Code: FOZ
• UDI-Device Identifier: 10801902102536
• UDI-Public: 10801902102536
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024

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: 09/30/2024
• Device Catalogue Number: CV-47702-E
• Device Lot Number: 71F22K2374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown