BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEGA 8FR. 50CC IAB

    MDR report key: 3931267 · Received June 23, 2014

    Report

    Report Number
    2248146-2014-00216
    Event Type
    Death
    Date Received
    June 23, 2014
    Date of Event
    September 10, 2013
    Report Date
    September 16, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CONDITION RECEIVED: THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD FOUND ON THE EXTERIOR OF THE CATHETER WITH THE ONE-WAY VALVE ATTACHED. THE SHEATH WAS NOT RETURNED FOR EVAL. PRODUCT EVAL: VACUUM WAS APPLIED TO THE IAB USING THE RETURNED ONE-WAY VALVE AND IT HELD VACUUM. A LABORATORY INSERTION TEST WAS PERFORMED USING AN 8FR LABORATORY SHEATH SINCE THE SHEATH WAS NOT RETURNED FOR EVAL. THE TECHNICIAN WAS ABLE TO SUCCESSFULLY MANUALLY WRAP AND INSERT THE BALLOON THROUGH THE SHEATH. AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING AND EXTRACORPOREAL TUBING WAS PERFORMED AND NO LEAKS WERE DETECTED. A LEAK MAY IMPACT THE ABILITY TO MAINTAIN VACUUM. CONCLUSION: THE REPORTED EVENT CANNOT BE CONFIRMED BY THE EVAL. THE INSTRUCTIONS FOR USE INDICATES TO NOT REMOVE THE IAB FROM THE T-HANDLE UNTIL IMMEDIATELY PRIOR TO INSERTION AND LEAVE THE ONE-WAY VALVE SECURELY IN PLACE TO ENSURE VACUUM IS MAINTAINED. IF THE ONE-WAY VALVE IS REMOVED OR NOT PROPERLY ATTACHED TO THE CATHETER WITH A VACUUM IT CAN RESULT IN THE BALLOON UNFURLING AND CAUSE THE IAB TO BE DIFFICULT TO INSERT THROUGH THE SHEATH. IT ALSO INDICATES THAT WHEN ADVANCING THE IAB, MAINTAIN HOLDING THE IAB CATHETER AT A LOCATION WITHIN 2.5CM OF THE INSERTION SECTION, ADVANCING THE IAB CATHETER SHOULD ALWAYS BE PERFORMED IN SHORT, ONE INCH CONTINOUS STROKES. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL HAS REPORTED THAT THEIR MEGA CATHETER, LOT # 2893, WOULD NOT GO THROUGH THE SHEATH. BALLOON WAS NOT INSERTED IN PT, SHEATH REMAINED IN PLACE AND A LINEAR 40CC WAS SUCCESSFULLY INSERTED. PLEASE SEND A RETURN KIT TO THE ATTENTION OF THE NURSE IN THE CARDIAC CATH LAB. I WILL BE SENDING HER THE BALLOON DATA SHEET TO FILL OUT AND RETURN WITH THE MEGA 50 CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367012 MEGA 8FR. 50CC IAB INTRA-AORTIC BALLON DSP DATASCOPE CORP. 0684-00-0497 2893

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death