BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEGA 8FR 50CC IAB

    MDR report key: 3760691 · Received April 8, 2014

    Report

    Report Number
    2248146-2014-00048
    Event Type
    Death
    Date Received
    April 8, 2014
    Date of Event
    February 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K091449
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION ON 03/11/2014 AND SENT FOR DECONTAMINATION PRIOR TO TESTING. VISUAL INSPECTION OF THE DEVICE WAS PERFORMED. THE MEMBRANE WAS FOUND LOOSELY FOLDED WITH BLOOD ON THE EXTERIOR OF THE DEVICE. THE SHEATH WAS RETURNED LOOSE IN THE PACKAGE. PHYSICAL TESTING OF THE COMPONENTS WAS PERFORMED. THE RETURNED SHEATH WAS FOUND TO BE WITHIN SPECIFICATION. A LABORATORY INSERTION TEST WAS PERFORMED AND THE BALLOON WAS PASSED SUCCESSFULLY THROUGH THE RETURNED 8FR SHEATH. AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING AND EXTRACORPOREAL TUBING WAS PERFORMED AND NO LEAKS WERE DETECTED WHICH COULD IMPACT THE DEVICES ABILITY TO MAINTAIN A VACUUM. THE REPORTED INSERTION DIFFICULTY COULD NOT BE CONFIRMED AS THE RETURNED COMPONENTS WERE FOUND WITHIN SPECIFICATION AND PASSED ALL LABORATORY TESTING. A DEVICE AND LOT HISTORY RECORD REVIEW WAS PERFORMED AND TO NON-CONFORMITIES WERE FOUND RELATED TO THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO INSERT THE IAB, BUT COULD NOT PASS THROUGH THE SHEATH. ANOTHER IAB WAS USED TO COMPLETE THE PROCEDURE WITHOUT DIFFICULTY. IT WAS REPORTED THAT THE PATIENT EXPIRED AT A LATER DATE, HOWEVER, IT WAS NOT RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210491 MEGA 8FR 50CC IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0497 2930

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death