MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM; CATHETER HEMODIALYSIS NON IMPL

Model Number IPN919690

Device Problems Unraveled Material (1664); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2023

Event Type  malfunction  

Event Description

During the insertion of the catheter, "the needle unraveled the swg during removal".The physician slowly removed the catheter and guidewire together and another device was used.No patient harm was reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn # (b)(4).The customer returned an opened hemodialysis kit with a guide wire assembly and an introducer needle for evaluation.The guide wire was partially advanced through the introducer needle and was unraveled.The components showed evidence of use in the form of dried blood.Visual examination revealed the guide wire was unraveled from the distal weld and is kinked/distorted in several locations along the body.The returned introducer needle showed evidence of use but no obvious defects or anomalies.The separation point of the core wire was towards the distal end of the guide wire.The guide wire was removed from the introducer needle as part of this investigation.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the distal weld.The exposed distal core wire tip was tapered and discolored at the point of separation.Both welds were present and appeared full and spherical.The bends in the guide wire measured approximately 19mm and 31mm from the proximal tip.The broken core wire measured 704mm which is within the specification limits of 694mm - 706mm per the guide wire product drawing; therefore no pieces of the core wire appear to be missing.The outer diameter of the guide wire measured 0.942mm which is within the specification limits of 0.94mm - 0.965mm per the guide wire product drawing.The outer diameter of the needle cannula measured 0.04965", which is within the specification limits of 0.0495"-0.0505" per the needle cannula product drawing.The inner diameter of the needle cannula measured 0.041" which is within the specification limits of 0.041" - 0.043" per the needle cannula product drawing.The guide wire was functionally tested per the instructions for use (ifu) provided with this kit, which states "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was removed from the 18ga introducer needle, and the needle was used to functionally test the proximal end of the guide wire.The undamaged portions of the guide wire passed through the needle cannula with little to no difficulty.A manual tug test confirmed that the proximal weld was secure and intact.A device history record review was performed, and there were no relevant findings.The instructions for use (ifu) provided with the kit warns the user, "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." in addition, "warning: 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 adjacent to the distal weld.The guide wire and needle met all functional and dimensional requirements during investigation testing.No manufacturing defects were found during this investigation.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.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 caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

During the insertion of the catheter, "the needle unraveled the swg during removal".The physician slowly removed the catheter and guidewire together and another device was used.No patient harm was reported.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM
• Type of Device: CATHETER HEMODIALYSIS NON IMPL
• 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: 17304819
• MDR Text Key: 318831636
• Report Number: 3006425876-2023-00654
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801902100122
• UDI-Public: 00801902100122
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K991431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2023

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
• Device Operator: Health Professional
• Device Model Number: IPN919690
• Device Catalogue Number: CS-12142-F
• Device Lot Number: 71F22C0974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 07/31/2023
• Supplement Dates FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED