BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA 8FR. 50CC IAB

    MDR report key: 18426561 · Received January 2, 2024

    Report

    Report Number
    2248146-2024-00004
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    December 7, 2023
    Report Date
    October 22, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107301
    PMA / PMN Number
    K133074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IAB WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND TRACES OF BLOOD ON THE EXTERIOR OF THE CATHETER. NO BLOOD WAS OBSERVED INSIDE THE IAB CATHETER. A KINK WAS ON THE INNER LUMEN WITHIN THE MEMBRANE APPROXIMATELY 3.8CM FROM THE IAB TIP. AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING AND EXTRACORPOREAL TUBING WAS PERFORMED AND NO LEAKS WERE DETECTED. THE REPORTED EVENT CANNOT BE CONFIRMED BY THE EVALUATION. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NONCONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. REFERENCE COMPLAINT #(B)(4).

    Additional Manufacturer Narrative · 0

    COMPLETE EVENT SITE NAME - (B)(6) HOSPITAL. EVENT SITE POSTAL CODE: 100048. 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

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID. REFERENCE COMPLAINT (B)(4).

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THERAPY, BLOOD WAS SEEN INSIDE THE INTRA-AORTIC BALLOON (IAB) MEMBRANE. A NEW IAB WAS INSERTED TO CONTINUE THERAPY WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409977 MEGA 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0684-00-0498-01 3000317888 10607567107301

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male