MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 8 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-15802-E
Medical Device Problem Codes	Material Separation (1562); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
It was reported the spring wire guide kinked during use on the patient.The wire was stuck in the dilator and during removal, "the wire was broken at the part outside the patient body".A new device was used to complete the procedure.There was no patient harm.The patient's condition is reported as fine.
Event or Problem Description
It was reported the spring wire guide kinked during use on the patient.The wire was stuck in the dilator and during removal, "the wire was broken at the part outside the patient body".A new device was used to complete the procedure.There was no patient harm.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer provided two photos showing a damaged guide wire and the kit lidstock for analysis.The dilator involved with this complaint is not pictured.The customer also returned one swg and lidstock for analysis.The dilator was not returned.No obvious signs of use were observed on the guide wire.Visual examination revealed that the guide wire was separated into two portions with both the coil and core wires broken.There was one kink at the distal end, towards the separation point, of the proximal portion of the guide wire.The separation points of the core wire for both portions of the guide wire were fractured.The core wires were still attached to their respective welds.Microscopic examination confirmed the defects, and both welds were full and spherical.Visual analysis could not be performed on the dilator as it was not returned for investigation.The major kink in the guide wire measured 90mm from the proximal tip.The proximal portion of the core wire measured 128mm and the distal portion of the core wire measured 276mm.The total length of the core wire measured 404mm which is not within the specification limits of 596-604mm per the guide wire product drawing; therefore, at least 192mm of the guide wire was not returned.The guide wire outer diameter measured 0.798mm, which is within the specification limits of 0.788mm-0.826mm per the guide wire product drawing.Functional testing could not be performed on the guide wire due to the nature of the damage.A manual tug test revealed that both welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu 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 customer report of a separated guide wire was confirmed through examination of the returned sample.The dilator was not returned.Visual examination revealed that both the core and coil wires were broken.At least 192mm of the guide wire was determined to be missing.A device history record review was performed, and no relevant findings were identified.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso (b)(4) standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error likely contributed to this event, however, the probable cause of guide wire and dilator resistance could not be determined based upon the information provided and without the dilator being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 8 FR X 20 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: 17729882
• Report Number: 3006425876-2023-00871
• Device Sequence Number: 6134899
• Product Code: DQY
• UDI-Device Identifier: 40801902127745
• UDI-Public: 40801902127745
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: CS-15802-E
• Device Lot Number: 71F22D2316
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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