MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW SAC KIT: 18 GA X 16CM; CATHETER PERCUTANEOUS

Catalog Number	SAC-01618-1A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "wire kinked upon insertion.No scar tissue, previous procedures and normal bmi on patient." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4) the customer returned a closed sac kit as a representative sample for evaluation.No signs of use were observed.The guide wire was assembled within the advancer assembly.No kinks or damage was observed in the guidewire.The distal j-bend was intact.Microscopic examination confirmed the kinks in the guide wire body.Both welds were present and were observed to be full and spherical.Visual inspection of the guidewire from the reported event could not be performed as it was not returned.The overall length of the guide wire measured 454 mm which is within the specification of 450-458 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.630 mm which is within the specification of 0.610-0.635 mm per guide wire product drawing.The guide wire was advanced through the returned ars and 18ga introducer needle to functionally test the guide wire.The guide wire passed through both components with no resistance.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 instructions for use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire.The report that the guide wire kinked during use was not confirmed through examination of the returned sample.The customer returned a representative sample, and no damage was observed on the guide wire.The returned guide wire met all relevant dimensional and functional requirements, and a device history record review did not identify any manufacturing related issues.Based on the condition of the returned sample and without the reported device returned for evaluation, the root cause could not be determined.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW SAC KIT: 18 GA X 16CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23817434
• Report Number: 9680794-2025-01034
• Device Sequence Number: 9350408
• Product Code: DQY
• UDI-Device Identifier: 10801902145496
• UDI-Public: (01)10801902145496(11)250802(17)271130(10)33F25F0231(21)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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: SAC-01618-1A
• Device Lot Number: 33F25F0231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2025
• 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
• Patient Sex: Unknown