MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC KIT: 2-LUMEN 7 FR X 16 CM; CATHETER PERCUTANEOUS

Catalog Number	AK-12702-J
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the user was unable to insert the swg through the catheter because of resistance.Therefore, the catheter and the swg were removed and replaced with a new kit to complete the procedure.No injury to the patient occurred." the returned device was kinked.
Event or Problem Description
It was reported that: "the user was unable to insert the swg through the catheter because of resistance.Therefore, the catheter and the swg were removed and replaced with a new kit to complete the procedure.No injury to the patient occurred." the returned device was kinked.
Additional Manufacturer Narrative
(b)(4) the customer returned one guide wire assembly and a lidstock for analysis.Signs of use in the form of biological material were observed on the guide wire surface and inside the guide wire tubing.The catheter involved with this complaint was not returned.Visual analysis revealed that the guide wire was kinked towards the distal end.This resulted in the distal j-bend to be misshapen.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.Visual analysis could not be performed on the catheter involved with this complaint as it was not returned.The kinking on the guide wire measured 435mm from the proximal weld.The guide wire total length measured 457mm, which is within the specification limits of 450mm-458mm per the guide wire product drawing.The guide wire outer diameter measured 0.616mm, which is within the specification limits of 0.610mm-0.635mm per the guide wire product drawing.The guide wire was inserted through a lab inventory 7fr cvc catheter.Little to no resistance was encountered as the guide wire passed completely through the catheter.Performed per ifu statement , "thread tip of catheter over guidewire".A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs 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 ifu also states, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed that the guide wire was kinked.The guide wire also met all relevant dimensional and functional requirements.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, the root cause cannot be determined as the actual catheter involved with this complaint was not returned.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: section d.4.- unique identifier (udi) (b)(4).

• Brand Name: CVC KIT: 2-LUMEN 7 FR X 16 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 19526850
• Report Number: 3006425876-2024-00662
• Device Sequence Number: 7488535
• Product Code: DQY
• UDI-Device Identifier: 00801902101921
• UDI-Public: 00801902101921
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 08/31/2025
• Device Catalogue Number: AK-12702-J
• Device Lot Number: 71F22C1226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2022
• 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