BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANS-RAY 7FR. 34CC IAB

    MDR report key: 20317130 · Received September 27, 2024

    Report

    Report Number
    2248146-2024-0000593
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    September 4, 2024
    Report Date
    November 15, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567106755
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT SITE POSTAL CODE: 510-0822 THIS EVENT OCCURRED ON THE JAPANESE MARKET WITH A TRANSRAY 34CC IAB, WHICH IS A SIGNIFICANTLY SIMILAR DEVICE TO A SENSATION 34CC, WHICH IS SOLD IN THE US. FOR D4: DI NUMBER HAS BEEN USED FOR SENSATION 34CC OR (B)(4)., WHICH IS SOLD IN THE USA. PROVIDED D4 LOT NUMBER, D4 EXPIRATION DATE, AND H4 DEVICE MANUFACTURE DATE CORRESPONDING TO TRANSRAY DEVICE INVOLVED IN THE EVENT, WHICH IS NOT AVAILABLE IN USA. 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

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. REFERENCE COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED DURING INSERTION, THE INTRA-AORTIC BALLOON (IAB) MEMBRANE BECAME UNFURLED AND THE IAB COULD NOT BE INSERTED. A NEW IAB WAS INSERTED TO PROVIDE THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371491 TRANS-RAY 7FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0684-00-0576-10 3000300045 10607567106755

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown