MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH KIT: 20 GA X 12 CM; WIRE, GUIDE, CATHETER

Catalog Number	NA-04550-1A
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "met resistance while inserting the guidewire.Tried to straighten distal end of guidewire by holding wire intact and pulling.Did not pull wire back.Physician rotated needle in case bevel was next to wire without any improvement.Removed entire wire w/needle.Looking at wire when it was removed, physician thought the wire was weakened at distal tip above jtip".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 one guide wire for evaluation.The 20ga introducer needle and guide wire assembly were not returned.Visual examination revealed the guide wire had three kinks with offset coils towards the distal end and showed signs of use in the form of biological material.The distal j-bend was slightly misshapen but intact.Both welds appeared full and spherical.Visual inspection of the introducer needle could not be performed as the needle was not returned.The kinks in the guide wire were located 15 mm, 35 mm, and 48 mm from the distal tip.The overall length of the guide wire measured 354 mm which is within the specification limits of 350.0-355.6 mm.The outer diameter (od) of the guide wire measured 0.610 mm which is within the specification limits of 0.610-0.635 mm.Dimensional inspection of the introducer needle could not be performed as the needle was not returned.The guide wire was advanced through a lab inventory 20ga introducer needle to functionally test the guide wire.The undamaged portions of the guide wire passed through with little to no resistance.Performed per the instructions-for-use (ifu) statement "insert tip of guidewire through introducer needle into artery (until depth-marking [if provided] on wire enters hub of needle)." functional inspection of the introducer needle could not be performed as the needle was not returned.A manual tug test confirmed that both the distal and proximal welds were intact.All complaints are trended across product families on a monthly basis.A device history record review could not be performed as no lot number was provided and sales history could not be obtained.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, "precaution: use care when removing guidewire.If resistance is encountered, remove guidewire and catheter together as a unit.Use of excessive force may damage catheter or guidewire." corrective action is not required at this time as the probable cause could not be determined based upon the information provided and without the needle returned.The report that the guide wire was kinked was confirmed through examination of the returned sample.The guide wire had three kinks towards the distal end.The introducer needle was not returned.The guide wire passed all relevant dimensional/functional inspections, and a device history record review did not reveal any evidence of a manufacturing related issue.Based on these circumstances, unintentional use error likely contributed to this event, however, the probable cause of guide wire and needle resistance could not be determined based upon the information provided and without the needle being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW RA CATH KIT: 20 GA X 12 CM
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 19103103
• Report Number: 9680794-2024-00328
• Device Sequence Number: 18076913
• Product Code: DQX
• UDI-Device Identifier: 30801902117367
• UDI-Public: 30801902117367
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/19/2024

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: NA-04550-1A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 04/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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.
• Patient Sex: Unknown