BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK¿ ADVANCER

    MDR report key: 2972979 · Received February 21, 2013

    Report

    Report Number
    2134265-2013-01050
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2013-01049 AND 2134265-2013-01071. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY INTERVENTION PROCEDURE, A BLOOD PRESSURE ISSUE OCCURRED. THE 95% STENOTIC LESION WAS LOCATED IN THE SEVERELY CALCIFIED RIGHT CORONARY ARTERY. THE PHYSICIAN PLACED A ROTAWIRE GUIDEWIRE IN THE LESION AND THEN CONNECTED A 1.25 MM ROTALINK BURR TO A ROTALINK ADVANCER. DURING ADVANCEMENT OF THE BURR TO THE LESION THE ADVANCER BEGAN LEAKING AIR AT THE INLET PORT. THE ROTALINK BURR WAS REMOVED FROM THE PATIENT AND THE PATIENT'S BLOOD PRESSURE REMAINED NORMAL. THE PHYSICIAN CONNECTED THE ROTALINK BURR TO ANOTHER ROTALINK ADVANCER AND DURING TESTING OUTSIDE THE BODY, THE ADVANCER HAD A LARGE AIR LEAK NOISE. AT THIS POINT IN THE PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED AND WAS TREATED WITH MEDICATION. THE PHYSICIAN DECIDED TO STOP AND RESCHEDULE THE PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75882 ROTALINK¿ ADVANCER CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H80222782001A0 14136214

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention 1.25MM ROTALINK BURR| ROTAWIRE GUIDE WIRE