BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET

    MDR report key: 2240654 · Received July 27, 2011

    Report

    Report Number
    2240654
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 25, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011: PATIENT WITH ACUTE INFERIOR WALL MI UNDERWENT EMERGENT CORONARY ANGIOGRAM, STENT(S) PLACED, THROMBUS EXTRACTED. PATIENT WENT INTO CARDIOGENIC SHOCK, IABP WAS PLACED WITH 1:1 AUGMENTATION, INTUBATED, AND MAINTAINED ON VASOPRESSORS. ON (B)(6) 2011 - MULTIPLE ALARMS FROM IABP. IABP SWITCHED TO NEW IABP. ALARMS CONTINUED THEN "BLOOD DETECTED" ALARM, AND UNIT SHUT DOWN. ON (B)(6) 2011: ATTEMPT REMOVAL OF IAB CATHETER FAILED AND BALLOON APPEARED "STUCK". EMERGENTLY A VASCULAR SURGEON WAS ABLE TO REMOVE CATHETER PERCUTANEOUSLY BY UP SIZING THE SHEATH TO AN 11 FR. PATIENT LOST PULSE TO LEFT LEG DURING PROCEDURE AND EMERGENT ARTERIOGRAM REVEALED OCCLUSION OF FEMORAL ARTERY. EMERGENT LEFT FEMORAL ENDARTERECTOMY, THROMBECTOMY AND PATCH ANGIOPLASTY PERFORMED. PATIENT REMAINED HYPOTENSIVE ON MAX THERAPY. ECHO REVEALED LARGE VSD (NOT PRESENT (B)(6)). ON (B)(6) 2011, PATIENT TRANSFERRED FOR HIGHER LEVEL SURGICAL CARE TO (B)(6) MEDICAL CENTER FOR URGENT REPAIR OF THE VSD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET SENSATION:7F INTRA-AORTIC BALLOON DSP MAQUET CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| O| R SEE RELEVANT TESTS