MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW REDIGUARD IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	IPN915325
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
Middle-aged male with acute onset of chest pain.Procedure: heart catheterization.Upon insertion of the arrow balloon, it started leaking blood.Device removed and another one used, without known harm to patient.Manufacturer response for rediguard iab, rediguard iab (per site reporter), will obtain.

• Brand Name: ARROW REDIGUARD IAB
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 19078302
• Report Number: 19078302
• Device Sequence Number: 15058938
• Product Code: DSP
• UDI-Device Identifier: 10801902161977
• UDI-Public: (01)10801902161977(17)250930(10)18F23K0002(JY32037
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/20/2024
• Report Date (Section F): 03/20/2024

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 Model Number: IPN915325
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F23K0002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Sex: Male
• Patient Weight: 104 KG
• Date Report Sent to FDA: 03/20/2024