MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTI-LUMEN/PSI SET; INTRODUCER CATHETER

Catalog Number	SI-11242
Medical Device Problem Codes	Degraded (1153); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "problems were encountered with removing the guide inside the patient; once it was removed, it was found to be partly decomposed." the device was removed and replaced.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire and an 18 ga introducer needle for analysis.The guide wire was advanced through the introducer needle and was unraveled adjacent to the needle hub.Signs of use in the form of biological material were observed on and within the returned components.Visual analysis revealed the guide wire was unraveled towards the distal end and has multiple kinks along the body.Dried biological material was observed on the guide wire and within the introducer needle when the guide wire was removed.Microscopic analysis 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.No defects or anomalies were observed on the introducer needle.The guide wire was removed from the introducer needle.The major kinks in the guide wire body measured 193 mm, 410 mm, and 443 mm from the proximal tip.The broken core wire measured 450 mm in length, which is within the specification limits of 450-458 mm per guide wire product drawing; therefore, no pieces of the core wire appear to be missing.The outside diameter of the guide wire measured 0.851 mm, which is within the specification limits of 0.838-0.877 mm per guide wire product drawing.The needle cannula outer diameter measured 0.0497", which is within the specification limits of 0.0495"-0.0505" per 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 needle cannula product drawing.The guide wire and introducer needle were functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the returned guide wire was advanced through the returned introducer needle, and the undamaged portions of the guide wire advanced through with little to no resistance.A manual tug test confirmed the proximal weld was intact.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing guidewire, dilator, or access device.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 of a guide wire/needle resistance with an unraveled guide wire was confirmed through complaint investigation of the returned sample.Visual and functional analysis revealed that the guide wire met resistance due to a build-up of biological material inside the needle.The guide wire and needle met all relevant dimensional and functional requirements.A device history record review did not identify any manufacturing related issues.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 11070:2014 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 and the customer description that the damage was observed during use, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "problems were encountered with removing the guide inside the patient; once it was removed, it was found to be partly decomposed." the device was removed and replaced.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW MULTI-LUMEN/PSI SET
• Common Device Name: INTRODUCER CATHETER
• 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: 20459689
• Report Number: 3006425876-2024-01004
• Device Sequence Number: 7718933
• Product Code: FOZ
• UDI-Device Identifier: 30801902144486
• UDI-Public: (01)30801902144486(11)230809(17)270728(10)71F23H0369(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K002507
• 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): 09/20/2024

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 Catalogue Number: SI-11242
• Device Lot Number: 71F23H0369
• 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: 09/20/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown