MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW SPRING WIRE GUIDE COMPONENT; WIRE GUIDE CATHETER

Model Number	IPN037337
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the spring wire guide bent during insertion.The issue occured with 3 devices on the same patient and a fourth attempt was successful.No patient harm was reported.The patient's condition is reported as fine.The additional devices are captured in mdr # 9680794-2022-00531 and 9680794-2022-00526.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The actual sample was not returned; however, the customer provided one photo for analysis.The complaint of kinked spring wire guide was not able to be confirmed by the photo.The photo only displayed the product lidstock.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 instructions for use (ifu) provided with this kit warns the user, "if resistance is encountered when attempting to remove spring-wire guide after catheter placement, spring-wire may be kinked about tip of catheter within vessel.To minimize the risk of spring-wire guide damage withdraw catheter relative to spring-wire guide about 2-3 cm and attempt to remove spring-wire guide.If resistance is again encountered remove spring-wire guide and catheter simultaneously." the customer report of kinked spring wire guide was not able to be confirmed by visual inspection of the customer supplied photo.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.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 the spring wire guide bent during insertion.The issue occured with 3 devices on the same patient and a fourth attempt was successful.No patient harm was reported.The patient's condition is reported as fine.The additional devices are captured in mdr # 9680794-2022-00531 and 9680794-2022-00526.

• Brand Name: ARROW SPRING WIRE GUIDE COMPONENT
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 15331906
• Report Number: 9680794-2022-00532
• Device Sequence Number: 6928197
• Product Code: DQX
• UDI-Device Identifier: 10801902128901
• UDI-Public: 10801902128901
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

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 Expiration Date: 07/31/2026
• Device Model Number: IPN037337
• Device Catalogue Number: AW-04018
• Device Lot Number: 14F21H0069
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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