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

Model Number	IPN918511
Medical Device Problem Codes	Unraveled Material (1664); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, "in the surgical emergency room, when the cvc was being inserted, the anaesthetist was unable to remove the swg.The swg was kinked and unravelled.A second device was used.No clinical consequences for the patient".
Additional Manufacturer Narrative
(b)(4).The customer returned one, guide wire and introducer needle for analysis.The lidstock was also returned.The guide wire was returned lodged inside the needle.Signs of use in the form of biological material were observed on the guide wire and inside the needle cannula.Visual analysis revealed that the guide wire was kinked in two locations.Offset coils were also observed adjacent to the distal weld.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.The major kinks on the guide wire measured 151mm and 231mm from the proximal weld.The offset coils measured 430mm, 435mm, 439mm, and 443mm from the proximal weld.The guide wire total length measured 455mm, which is within the specification limits of 450m-458mm per the guide wire product drawing.The guide wire outer diameter 0.61mm, which is within the specification limits of 0.61mm-0.635mm per the guide wire product drawing.After removal of the guide wire from the cannula, the inner diameter measured 0.032", which is within the specification limits of 0.032"-0.034" per the cannula product drawing.The outer diameter measured 0.050", which is within the specification limits 0.0495"-0.0505" per the cannula product drawing.Undue force was required to dislodge the guide wire from the cannula.Once removed, large quantities of dried biological material were observed exiting the cannula.The biological material was completely removed, and a lab inventory guide wire was then passed through the cannula.No resistance was encountered.Performed per the ifu statement "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".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 use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The ifu also states, "do not apply undue force on guidewire to reduce risk of possible breakage".The report of kinking due to guide wire/needle resistance was confirmed through complaint investigation.Visual analysis confirmed two major kinks and multiple offset coils across the guide wire.Both the guide wire and the needle cannula meta all relevant dimensional requirements.Functional testing revealed a build-up of dried biological material inside the needle cannula.Once the biological material was removed, a lab inventory guide wire passed with no issue.A device history record review was performed, and no findings were identified.Based on the customer report and the returned sample, the root cause is likely due to unintentional use error.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "in the surgical emergency room, when the cvc was being inserted, the anaesthetist was unable to remove the swg.The swg was kinked and unravelled.A second device was used.No clinical consequences for the patient.".

• Brand Name: ARROW CVC SET: 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: 21422168
• Report Number: 3006425876-2025-00189
• Device Sequence Number: 7987145
• Product Code: DQY
• UDI-Device Identifier: 00801902104694
• UDI-Public: (01)00801902104694(11)230222(17)280131(10)71F23B1454(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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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
• Operator of Device: Health Professional
• Device Model Number: IPN918511
• Device Catalogue Number: CS-12702-E
• Device Lot Number: 71F23B1454
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2023
• 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
• Patient Sex: Unknown