MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. / (SUBSIDIARY OF TELEFLEX, INCORPORATED) ARROW RADIAL ARTERY CATHETER; WIRE, GUIDE, CATHETER

Model Number	AK-04122
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Guidewire was pushed through the catheter and needle; catheter separated and became stuck in pt's artery.Catheter had to be removed with hemostats; found to be frayed.Fda safety report id # (b)(4).
Event or Problem Description
Guidewire was pushed through the catheter and needle; catheter separated and became stuck in pt's artery.Catheter had to be removed with hemostats; found to be frayed.Fda safety report id # (b)(4).

• Brand Name: ARROW RADIAL ARTERY CATHETER
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC. / (SUBSIDIARY OF TELEFLEX, INCORPORATED); reading PA 19805
• MDR Report Key: 13549447
• Report Number: MW5107535
• Device Sequence Number: 11729599
• Product Code: DQX
• UDI-Device Identifier: 20801902121572
• UDI-Public: (01)20801902121572
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/14/2022

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: 06/30/2023
• Device Model Number: AK-04122
• Device Lot Number: 13F21H0794
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Female