BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20962021 · Received December 18, 2024

    Report

    Report Number
    2248146-2024-0000769
    Event Type
    Malfunction
    Date Received
    December 18, 2024
    Date of Event
    September 30, 2024
    Report Date
    February 19, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K133074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO DECON OR VISUAL INSPECTION PERFORMED SINCE PRODUCT WAS NOT RETURNED AND COULD NOT BE EVALUATED. THEREFORE, WE WERE UNABLE TO CONFIRM OR DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. COMPLAINT ID NO. (B)(4).

    Additional Manufacturer Narrative · 0

    AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT HAS BEEN REPORTED ALREADY UNDER MFG REPORT NUMBER 2248146-2024-0000643. PLEASE REFER TO MFG REPORT NUMBER 2248146-2024-0000643 FOR ALL INFORMATION FOR THIS COMPLAINT EVENT. PLEASE CANCEL MFG REPORT NUMBER 2248146-2024-0000769 IN YOUR DATABASE.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION IN E1 FOR INITIAL REPORTER, THE FULL INITIAL REPORTER IS (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).

    Description of Event or Problem · 0

    IT WAS REPORTED VIA THE VOLUNTARY MEDWATCH MW5161802 THAT THE INTRA-AORTIC BALLOON PUMP (IABP) CONSOLE BEGAN ALARMING, AND A CHEST X-RAY INDICATED THE IABP CATHETER WAS DOUBLE BACKED ON ITSELF. THE IABP CATHETER WAS PULLED, AND THE PATIENT REMAINED STABLE. IT WAS POSSIBLE THAT THIS COULD BE A MODE OF FAILURE IN HOW IT IS MANUFACTURED AS THE DISTAL MARKER IS GLUED ONTO THE SHAFT OF THE BALLOON, RATHER THAN CLAMPED. DURING INSERTION, THE MORE FORCE THAT IS USED, THE DISTAL MARKER MAY BECOME MOBILE, LEADING IT TO DOUBLE BACK. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239369 SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET) SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0684-00-0576-01 3000397978

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male