MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 5 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-12402
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Udi# (b)(4).
Event or Problem Description
It was reported "swg kinked in 2 places in the package." this was found prior to use.There was no patient involvement.
Event or Problem Description
It was reported "swg kinked in 2 places in the package." this was found prior to use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The photo shows a guide wire containing a kink near the distal end.The customer also returned one opened cvc set with a guide wire for analysis.The guide wire was returned within its advancer tube.No obvious signs of use were observed.Visual inspection revealed several kinks and offset coils near the distal end of the guide wire body.The kinking in the guide wire was located within the guide wire segments that are protected by the assembly tubing during packaging, shipping, and handling.Microscopic examination confirmed both welds were present and spherical.The kinks on the guide wire measured 11mm, 13mm, and 27mm from the distal weld.The total length of the swg measured 452mm, which is within the specification limits of 449.2mm-458.8mm per the guide wire product drawing.The outer diameter of the swg measured 0.45mm, which is within specifications of 0.432-0.457mm per the guide wire product drawing.The returned swg was functionally tested per the instructions for use (ifu).The ifu provided with this kit states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".The undamaged portions of the wire passed through a lab inventory 21 ga introducer needle with minimal resistance.A manual tug test confirmed the distal and proximal welds were secure.Manufacturing was previously contacted regarding complaints of this nature.They confirmed that the guide wire assemblies are 100% inspected for kinking.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user, "do not use if package has been previously opened or damaged".The customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Visual inspection revealed several kinks and offset coils in the guide wire, within the sections of the guide wire that would be protected by the assembly tubing.Despite the damage, all relevant dimensional and functional requirements were met, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, the root cause cannot be determined.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 5 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: 19750211
• Report Number: 3006425876-2024-00710
• Device Sequence Number: 8987705
• Product Code: DQY
• UDI-Device Identifier: 30801902124310
• UDI-Public: (01)30801902124310(11)230914(17)280831(10)71F23J0503(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• 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): 06/24/2024

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 Catalogue Number: CS-12402
• Device Lot Number: 71F23J0503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown