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

Model Number	IPN915322
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Approximately 16 hours after insertion of an iapb (intra-aortic balloon pump) in the cath lab, the balloon membrane ruptured, and blood began to flow into the helium drive line.The line was clamped, the pump was stopped.Patient was taken to the cath lab to receive a replacement iabp, second device was inserted without issue.

• 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: 19095413
• Report Number: 19095413
• Device Sequence Number: 7737092
• Product Code: DSP
• UDI-Device Identifier: 10801902161946
• UDI-Public: (01)10801902161946
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/25/2024
• Report Date (Section F): 03/25/2024

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
• Device Model Number: IPN915322
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23J0006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 04/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Race: White
• Date Report Sent to FDA: 03/25/2024