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	Difficult to Remove (1528); Unraveled Material (1664); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "planned implantation of an arrow catheter after successful puncture, the guide wire cannot be advanced sufficiently.This is then withdrawn, but the spiral-shaped sheath stretches over the inner part.The guidewire cannot be removed from the vein." the guidewire was removed manually by the doctor.There was no patient harm or injury.The patient's current condition is reported as "fine.".
Event or Problem Description
It was reported "planned implantation of an arrow catheter after successful puncture, the guide wire cannot be advanced sufficiently.This is then withdrawn, but the spiral-shaped sheath stretches over the inner part.The guidewire cannot be removed from the vein." the guidewire was removed manually by the doctor.There was no patient harm or injury.The patient's current condition is reported as "fine.".
Additional Manufacturer Narrative
(b)(4).The customer provided three photos for analysis.The report of an unraveled guide wire was confirmed through the photos as they revealed unraveling of the coil wire at the location of the core wire separation.The customer returned multiple components of a cvc kit, including one guide wire assembly and introducer needle, for analysis.No definite signs-of-use were observed.Visual inspection revealed the guide wire coil wire was unraveled in the middle of the body due to a core wire separation.Microscopic examination confirmed that both welds were intact to the core and coil wires and were spherical.One kink was additionally observed on the guide wire body.Visual and microscopic examination of the needle revealed no obvious defects or anomalies.The kink in the guide wire measured 425mm from the proximal end.The broken core wire pieces measured a total of 455mm, which is within the specifications of 450-458mm per product drawing.The guide wire outer diameter measured 0.616 mm which is within the specifications of 0.610-0.635mm per product drawing.The inner diameter of the cannula measured 0.32", which is within the specification limits of 0.032"-0.034" per the cannula product drawing.The functional end of the guide wire was inserted through the cannula and no resistance was observed.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 the proximal and distal weld were secure and intact.A device history record review was performed with no relevant findings.The ifu provided with the kit informs the user, "do not apply undue force on guidewire to reduce risk of possible breakage".The ifu also states, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire".The report that the guide wire unraveled was confirmed through examination of the returned sample.The core wire was broken towards the distal j-bend, resulting in unraveling of the coil wire.Despite this, the guide wire passed all relevant dimensional and functional requirements, and a device history record review revealed no relevant manufacturing findings.Based on these circumstances, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• 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: 20098075
• Report Number: 3006425876-2024-00855
• Device Sequence Number: 12872318
• Product Code: DQY
• UDI-Device Identifier: 00801902104694
• UDI-Public: (01)00801902104694(11)240228(17)290131(10)71F24B0769(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 08/07/2024

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
• Operator of Device: Health Professional
• Device Model Number: IPN918511
• Device Catalogue Number: CS-12702-E
• Device Lot Number: 71F24B0769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• 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