BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSATION 7FR. 34CC IAB

    MDR report key: 24869855 · Received April 14, 2026

    Report

    Report Number
    2248146-2026-0000897
    Event Type
    Death
    Date Received
    April 14, 2026
    Report Date
    April 14, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D4 (UDI), D9, D10, E2, E3, G3, G6, H2, H3, H6 (MEDICAL DEVICE PROBLEM CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS), H11 CORRECTED FIELD: G2 AN INTRA AORTIC BALLOON (IAB) LEAK IS THE LOSS OF INTEGRITY IN THE BALLOON MEMBRANE OR ITS CONNECTIONS, ALLOWING BLOOD OR GAS TO ENTER OR ESCAPE. PRODUCT WAS NOT RETURNED SO AN EXACT CAUSE OF THE ISSUE COULD NOT BE IDENTIFIED. HOWEVER, BASED ON OUR INVESTIGATION, A IAB LEAK CAN OCCUR DUE TO ONE OR MORE OF THE FOLLOWING PROBABLE CAUSES. CAUSES: IAB LEAKS CAN RESULT FROM THE FOLLOWING CASES: 1. MEMBRANE PERFORATIONS CAUSED BY: ABRASIONS, TEARS (PENETRATION BY SHARP OBJECTS). 2. CATHETER PERFORATIONS, SHARP OBJECTS, SEVERE KINKS; 3. INNER LUMEN BREAKS OR KINKS, 4. TIP LEAKS, 5. REAR SEAL LEAKS.

    Additional Manufacturer Narrative · 0

    EVENT SITE NAME: (B)(6) HOSPITAL. THE SERIAL NUMBER FOR THE MEDICAL DEVICE REFERRED TO IN THIS MEDICAL DEVICE REPORT HAS NOT BEEN RECEIVED, AND THEREFORE, NO UDI NUMBER CAN BE PROVIDED. UPON COMPLETION OF THE INVESTIGATION INTO THIS EVENT A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE SENSATION 34CC BALLOON CATHETER RUPTURED. PATIENT DIED. NO MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940355 SENSATION 7FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0684-00-0469-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death