MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI SET: 8.5 FR; INTRODUCER, CATHETER

Catalog Number	SI-09875-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the swg was kinked during use.Therefore, a new kit was used to complete the procedure.No injury to the patient occurred." there was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the swg was kinked during use.Therefore, a new kit was used to complete the procedure.No injury to the patient occurred." there was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).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.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported "the swg was kinked during use.Therefore, a new kit was used to complete the procedure.No injury to the patient occurred." there was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire without its protecting tube and advancer.Signs of use were observed on the guide wire.The guide wire was observed to have one kink towards the distal end, adjacent to the j-bend.The distal j-bend was intact.Offset coils adjacent to the j-bend were also observed.Microscopic examination confirmed the damage to the guide wire body.Both welds were present and appeared to be full and spherical.The kink in the guide wire was located 446 mm from distal end.The offset coils were observed at 443mm,450mm and 451mm from distal end.The overall length of the guide wire measured 455mm, which is within the specification limits of 450-458mm per guide wire product drawing.The outer diameter of the guide wire measured 0.856mm, which is within the specification limits of 0.838-0.877mm per guide wire product drawing.The guide wire was 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 (or catheter)." the guide wire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle to functionally test the guide wire.The guide wire encountered slight resistance when the kinked area passed through the lab inventory ars and an 18ga lab inventory introducer needle.However, complete resistance was encountered, and passage was not possible, when the offset coil area was advanced.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution , "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 kinked during use was confirmed through complaint investigation of the returned sample.A single kink was observed toward the distal end, adjacent to the j-bend.The distal j-bend was intact.Offset coils adjacent to the j-bend were also noted.The returned guide wire met all relevant dimensional/functional requirements, and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PSI SET: 8.5 FR
• 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: 22310065
• Report Number: 3006425876-2025-00574
• Device Sequence Number: 20853589
• Product Code: DYB
• UDI-Device Identifier: 00801902102867
• UDI-Public: (01)00801902102867(11)240510(17)280728(10)71F24E0363(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K780532
• 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,Followup
• Report Date (Section B): 06/03/2025

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 Catalogue Number: SI-09875-E
• Device Lot Number: 71F24E0363
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 07/23/2025; 08/21/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/31/2025; 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2024
• 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.; NOT REPORTED.
• Patient Sex: Unknown