MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Model Number	IPN918754
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the swg got stuck in the needle during insertion.Unable to remove the swg from the needle.Needle removed with the swg and new kit opened." the returned device was unraveled.The patients current condition is reported as "deceased" but there was no reproted patient harm or consequence from the reported incident.
Event or Problem Description
It was reported that "the swg got stuck in the needle during insertion.Unable to remove the swg from the needle.Needle removed with the swg and new kit opened." the returned device was unraveled.The patients current condition is reported as "deceased" but there was no reproted patient harm or consequence from the reported incident.
Additional Manufacturer Narrative
(b)(4).Additional information received 17-may-2024 indicates the incident reported was not linked to the patient's death.The customer returned one guide wire assembly and one 18ga introducer needle for analysis.Signs of use in the form of biological material were observed.Visual analysis of the guide wire revealed that it was unraveled towards the distal end.The unraveled portion was lodged inside the introducer needle.Moderate force was required to free the guide wire.Once freed, a large mass of dried biological material was observed on the coils of the guide wire.Further microscopic examination confirmed the damage.The core wire separated directly adjacent to the distal weld.The distal and proximal welds appeared full and spherical upon receipt.The broken core wire measured 602mm in length, which is within the specification of 596mm-604mm per the guide wire product drawing.The outside diameter of the guide wire measured 0.805mm, which is within the outer diameter specification of 0.788mm-0.826mm per the guide wire product drawing.The needle cannula outer diameter measured 0.0505", which is within the specification limits of 0.0495"-0.0505" per the cannula product drawing.The cannula inner diameter measured 0.041", which is within the specification limits of 0.041"-0.043" per the cannula product drawing.Moderate force was required to remove the guidewire from the cannula.A large mass of dried biological material was observed on the unraveled spring coil wire.Once removed, the proximal end of the guide wire was inserted through the needle cannula with little to no resistance.Performed per 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 proximal weld was intact.A device history record review was performed, and no relevant manufacturing issues were identified.The ifu provided with the kit informs the user, "warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." additional information received by the customer indicated that the customer confirmed the clinician pulled the swg back against the introducer needle bevel."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 report that the guide wire unraveled was confirmed through examination of the returned sample.The core wire was broken adjacent to the distal weld.The guide wire and needle met all dimensional and functional requirements during investigation testing.No manufacturing defects were found during this investigation.A review of the additional information provided by the customer revealed that they retracted the guidewire back against the needle bevel during the removal attempt.The ifu provided with the kit warns the user, "warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire.".Therefore, based on the customer provided information and evidence on the sample, the root cause of this event is intentional use error as the customer did not follow the instructions provided in the ifu.An in-service request has been initiated to instruct the customer on proper use of the device.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 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: 19309805
• Report Number: 3006425876-2024-00521
• Device Sequence Number: 16913181
• Product Code: DQY
• UDI-Device Identifier: 30801902125959
• UDI-Public: 30801902125959
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

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: IPN918754
• Device Catalogue Number: CS-15703
• Device Lot Number: 71F23A1459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown