BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET)

    MDR report key: 24637600 · Received March 19, 2026

    Report

    Report Number
    2248146-2026-0000792
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    February 26, 2026
    Report Date
    April 10, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108605
    PMA / PMN Number
    K133074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTERIZATION LIMIT E1: INITIAL REPORTER AND EVENT SITE NAME: (B)(6). THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. IF PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS. COMPLAINT RECORD ID (B)(4).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H11 CORRECTED FIELDS: D4 (UDI) AND E1 (EVENT SITE NAME) DUE TO CHARACTER LIMIT IN BLOCK E1 FULL EVENT SITE NAME IS (B)(6). THE UDI IS INCOMPLETE BECAUSE THE LOT NUMBER AND SERIAL NUMBER ARE UNKNOWN.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS B4, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS COMPONENT CODE INVESTIGATION CONCLUSIONS), H11. PRODUCT WAS NOT RETURNED SO AN EXACT CAUSE OF THE ISSUE COULD NOT BE IDENTIFIED HOWEVER BASED ON OUR INVESTIGATION A UNABLE TO MONITOR PRESSURE WAVEFORM CAN OCCUR DUE TO ONE OR MORE OF THE FOLLOWING PROBABLE CAUSES. A CONDITION IN WHICH THE INTRA AORTIC BALLOON PUMP IABP CANNOT OBTAIN A RELIABLE ARTERIAL PRESSURE WAVEFORM DUE TO ISSUES SUCH AS SENSOR FAILURE FIBER OPTIC IAB CALIBRATION FAILURE OR DISCONNECTION AND OR FIBER OPTIC BREAK CATHETER LUMEN OBSTRUCTION EG CLOT, KINK, OR LUMEN DAMAGE. SETUP OR EQUIPMENT PROBLEMS EG IMPROPER ZEROING AIR BUBBLES DAMPING LOOSE CONNECTIONS OR PATIENT RELATED FACTORS LIKE LOW PULSE PRESSURE OR ARRHYTHMIAS IN THESE SITUATIONS THE ARTERIAL SIGNAL BECOMES INACCURATE OR UNUSABLE FOR SAFE IABP OPERATION. CAUSES OF ARTERIAL PRESSURE: BLOOD CLOT THROMBUS FORMATION WITHIN THE INNER LUMEN, A BREAK IN THE INNER LUMEN, A KINK IN THE INNER LUMEN, FIBER OPTIC IAB CALIBRATION FAILURE OR DISCONNECTION, FIBER OPTIC CABLE BREAK, FIBER OPTIC CABLE KINK, TRANSDUCER NOT ZEROED OR VENTED PROPERLY, OVER DAMPED OR FLAT ARTERIAL PRESSURE WAVEFORM DUE TO BUBBLES OR EXCESSIVE TUBING COMPLIANCE, LOOSE OR INCORRECT PRESSURE CABLE CONNECTIONS, PATIENT CONDITION LOW PULSE PRESSURE ARRHYTHMIAS, OFF LABEL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, WHILE USING SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON (IAB), FIBER OPTIC ON CATHETER READING INCORRECT PRESSURE. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228403 SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET) SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0684-00-0576-01 10607567108605

    Patients

    Seq Age Sex Outcome Treatment
    1