MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) ARROW CATHETER, PERCUTANEOUS; RADIAL ARTERY CATHETERIZATION KIT

Model Number	IPN037160
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Radial artrey cath broke off in patient during insertion.Fda safety report id # (b)(4).

• Brand Name: ARROW CATHETER, PERCUTANEOUS
• Common Device Name: RADIAL ARTERY CATHETERIZATION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.); reading PA 19605
• MDR Report Key: 8757478
• Report Number: MW5087783
• Device Sequence Number: 19342851
• Product Code: DQY
• UDI-Device Identifier: 20801902121572
• UDI-Public: (01)20801902121572
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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: 06/30/2019
• Device Model Number: IPN037160
• Device Catalogue Number: AK-04122
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 102