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

Model Number	IPN038075
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
After insertion of a 40cc intraaortic balloon (iab) in the patient, while suturing the iab in place, blood was noted in the helium supply line and the loss of helium alarm went off.The iab was turned off and under fluoroscopy the shaft of the iab was noted to be fractured.The iab and its sheath were removed and replaced with a new 40cc iab and 9 fr.Brite tip sheath.

• Brand Name: ARROW
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 17595025
• Report Number: 17595025
• Device Sequence Number: 7420318
• Product Code: DSP
• UDI-Device Identifier: 00801902136695
• UDI-Public: (01)00801902136695
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 05/30/2023
• Report Date (Section F): 05/30/2023

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: IPN038075
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23A0037
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2023
• 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 Sex: Male
• Patient Weight: 88 KG
• Date Report Sent to FDA: 05/30/2023