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

Catalog Number	SI-21142
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn #(b)(4).
Event or Problem Description
It was reported "when using the catheter guide, when advancing through the needle, the equipment stays "stuck", not advancing in any direction and cannot be removed from the needle, becoming trapped in the middle of the needle (it cannot exit from it).When removing in block, the guide can finally be removed from the needle and is found "unhooked".The guidewire was replaced and successfully used.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "progressing well clinically".
Additional Manufacturer Narrative
(b)(4) the actual device was not returned; however, the customer provided one photo for analysis.Visual analysis revealed that the guide wire was unraveled from what appears to be the distal end; however, a complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The ifu also states, "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 ifu also states, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire".The customer report of an unraveled guide wire was confirmed by visual inspection of the customer supplied photo.Visual analysis of the photo revealed that the guide wire was unraveled from what appears to be the distal end.However, full complaint verification testing could not be performed as no sample was returned for analysis.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.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.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "when using the catheter guide, when advancing through the needle, the equipment stays "stuck", not advancing in any direction and cannot be removed from the needle, becoming trapped in the middle of the needle (it cannot exit from it).When removing in block, the guide can finally be removed from the needle and is found "unhooked".The guidewire was replaced and successfully used.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "progressing well clinically".

• 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: 22826907
• Report Number: 3006425876-2025-00822
• Device Sequence Number: 18533521
• Product Code: FOZ
• UDI-Device Identifier: 00801902102911
• UDI-Public: (01)00801902102911(11)240524(17)260312(10)71F24E0964(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K011761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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 Expiration Date: 03/12/2026
• Device Catalogue Number: SI-21142
• Device Lot Number: 71F24E0964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2024
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown