MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 14 GA X 8IN (20 CM); CATHETER PERCUTANEOUS

Model Number IPN917769

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

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

Event Date 06/24/2023

Event Type  malfunction  

Event Description

It was reported that: "when the central catheter was inserted, the guide was easily inserted but could not be removed.The guide had to be removed together with the needle.After removal, the needle was intact but the guide was completely unravelled.A check of the end of the guide was performed out to ensure that the entire guide had been removed (end was intact)." no additional guidewire was needed.The patient was reported to be "fine" after the procedure.

Manufacturer Narrative

Qn# (b)(4).

Manufacturer Narrative

(b)(4).The customer returned one guide wire and a lidstock for evaluation.The introducer needle was not returned.Visual examination revealed the guide wire was unraveled from the distal weld and had one kink on its body.Signs of use in the form of dried blood were observed on the guide wire.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.Visual analysis could not be performed on the needle as it was not returned.The kink in the guide wire measured 142mm from the proximal tip.The core wire measured 602mm which is within the specification limits of 596-604mm 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 0.796mm which is within the specification limits of 0.788mm-0.826mm per the guide wire product drawing.Dimensional analysis could not be performed on the needle as it was not returned.The proximal end of the guide wire was functionally tested per the instructions for use (ifu) provided with this kit, which states "the spring-wire guide should then be advanced in routine fashion to desired depth." the proximal end of the guide wire was advanced through a laboratory inventory ars/18ga introducer needle assembly.The undamaged portions of the guide wire passed through the needle cannula with little to no difficulty.Functional analysis could not be performed on the needle as it was not returned.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 , "warning: although the incidence of spring-wire guide failure is extremely low, practitioner should be aware of the potential for breakage if undue force is applied to the wire." the customer report of an unraveled guide wire was confirmed through examination of the returned sample.Visual examination revealed the guide wire was unraveled from the distal end.The guide wire met all relevant dimensional and functional requirements, however, the introducer needle was not returned.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.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 and the customer description, the root cause could not be determined as the introducer needle was not returned.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that: "when the central catheter was inserted, the guide was easily inserted but could not be removed.The guide had to be removed together with the needle.After removal, the needle was intact but the guide was completely unravelled.A check of the end of the guide was performed out to ensure that the entire guide had been removed (end was intact)." no additional guidewire was needed.The patient was reported to be "fine" after the procedure.

• Brand Name: ARROW CVC SET: 14 GA X 8IN (20 CM)
• Type of Device: 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: 17538053
• MDR Text Key: 321068539
• Report Number: 3006425876-2023-00771
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902105189
• UDI-Public: 00801902105189
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K862056
• 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: 07/21/2023

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 Model Number: IPN917769
• Device Catalogue Number: CV-04701
• Device Lot Number: 71F21E0485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/13/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2021
• 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