MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW RA CATH KIT: 22 GA X 1-3/8"; WIRE, GUIDE, CATHETER

Model Number	IPN037160
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the guidewire kinked causing the need to perforate the catheter".No patient injury or consequence reported.No medical intervention required.The patient's condition was reported to be critical prior to the procedure.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one radial arterial device and product lidstock for analysis.The needle was not returned.Signs of use in the form of biological material was observed on the guide wire tubing and the lidstock.Visual analysis revealed that the guide wire was kinked.The guide wire was able to fully deploy and retract within the advancer tubing.No other defects or anomalies were observed.The kink on the catheter measured at 15 mm from the distal end.The guide wire total length from the handle to the distal tip measured 4.5" which is within the specification of 4.4375" -4.6875" per the guide wire with handle graphic.The guide wire outer diameter measured 0.39 mm which is within the specification of 0.381 mm - 0.404 mm per the guide wire graphic.The guide wire tubing was attached to a lab inventory needle, with the returned catheter over needle over it.The guide wire was advanced and passed through both components with minimal resistance.Performed per ifu statement informs the user, "stabilize position of introducer needle and carefully advance spring-wire guide into vessel using spring-wire guide handle".A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not advance spring-wire guide unless there is free blood flashback in needle hub".The ifu also states, "if resistance is encountered during spring-wire guide advancement do not force feed, withdraw entire unit and attempt new puncture".The report of a kinked guide wire was confirmed through complaint investigation.Visual inspection revealed one kink in the guide wire body.The guide wire passed all relevant dimensional and functional requirements.A device history record review was performed with no relevant findings.Based on the customer report that the catheter kinked during use, and the findings of this investigation, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend of reports of this nature.
Event or Problem Description
It was reported "the guidewire kinked causing the need to perforate the catheter".No patient injury or consequence reported.No medical intervention required.The patient's condition was reported to be critical prior to the procedure.

• Brand Name: ARROW RA CATH KIT: 22 GA X 1-3/8"
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 13098488
• Report Number: 9680794-2021-00694
• Device Sequence Number: 4192817
• Product Code: DQX
• UDI-Device Identifier: 20801902121572
• UDI-Public: 20801902121572
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 12/08/2021

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: 04/30/2023
• Device Model Number: IPN037160
• Device Catalogue Number: AK-04122
• Device Lot Number: 13F21F1348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2021
• 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
• Patient Sex: Unknown