BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINEAR 7.5 FR. 40CC IAB

    MDR report key: 4091862 · Received August 21, 2014

    Report

    Report Number
    2248146-2014-00235
    Event Type
    Death
    Date Received
    August 21, 2014
    Date of Event
    June 24, 2012
    Report Date
    July 3, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CONDITION RECEIVED: THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE INTERIOR AND EXTERIOR OF THE CATHETER. THE EXTENSION TUBING WAS ALSO RETURNED. PRODUCT EVALUATION: AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING, EXTRACORPOREAL AND EXTENSION TUBING WAS PERFORMED AND ONE LEAK WAS DETECTED ON THE MEMBRANE APPROXIMATELY 2CM FROM THE REAR SEAL MEASURING 0.038CM IN LENGTH. CONCLUSION: UNDER MAGNIFICATION, A WHITISH PATCH WAS OBSERVED AROUND THE LEAK. THIS WHITISH PATCH IS THE TYPICAL APPEARANCE OF AN ABRASION MARK WHICH IS CAUSED BY CALCIFIED PLAQUE IN THE AORTA. THE MEMBRANE PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CONTACT WITH CALCIFIED PLAQUE DURING COUNTERPULSATION THERAPY. A REVIEW OF THE DEVICE HISTORY DOES NOT INDICATE ANY LOT SPECIFIC ISSUES. (B)(4).

    Description of Event or Problem · 1

    "BALLOON RUPTURE". BALLOON WAS REPLACED AFTER RUPTURE. IABP PUMPING ON PATIENT IN ICU. ICU NURSE NOTICED PATIENT BECAME HYPOTENSIVE AND NOTICED BLOOD IN IABP DRIVE LINE. NURSE CALLED SURGEON AND SURGEON REPLACED BALLOON. MEDWATCH RECEIVED IN MAIL ON (B)(6) 2010 STATING THE FOLLOWING: PATIENT CRITICALLY ILL IN ICU WITH INTRA-AORTIC BALLOON PUMP (IABP) S/P AORTIC VALVE REPLACEMENT. ON (B)(6) 2012 THE CARDIOTHORACIC SURGEON WAS CALLED WHEN THE PATIENT BECAME HYPOTENSIVE AND BLOOD WAS SEEN IN THE IABP DRIVE LINE. WITH ASEPTIC TECHNIQUE THE IABP WAS REMOVED AND A NEW IABP WAS INSERTED AND SUTURED IN PLACE; PATIENT'S BLOOD PRESSURE STABILIZED. CARDIOTHORACIC SURGEON DOCUMENTED INTERROGATION OF THE PREVIOUS IABP WITH AN OBVIOUS LEAK AT THE BALLOON TIP. ON (B)(6) THE PATIENT EXPIRED FROM HER UNDERLYING ILLNESS UNRELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506746 LINEAR 7.5 FR. 40CC IAB INTRA-AORTIC BALLOON DSP DATASCOPE CORP. 0684-00-0475 2735

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death