BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 3052425 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02875
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2013-02264 AND 2134265-2013-02875. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, REMOVAL DIFFICULTIES OCCURRED. VASCULAR ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY VIA AN UNSPECIFIED 6FR SHEATH. A 6FR Q 4.5 UNSPECIFIED (MACH1 OR RUNWAY) BSC GUIDE CATHETER WAS ADVANCED AND ANGIOGRAMS WERE OBTAINED. THE 67% STENOSED WITH A LUMINAL CROSS-SECTION OF 2.8MM TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED AND NON-TORTUOUS PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD) AT THE MAJOR SEPTAL PERFORATOR. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO CROSS THE LESION WITH A CHOICE FLOPPY GUIDE WIRE. THE PHYSICIAN UTILIZED THE 1.25MM ROTABLATOR ROTALINK PLUS BURR FOR 2-3 ABLATION RUNS IN THE PROXIMAL LAD, CONTINUING WITH THE SAME BURR IN THE MID LAD. A SPIRAL DISSECTION WAS THEN NOTED, RETROGRADE INTO THE LEFT MAIN TRUNK AND AORTA, AND THE LAD VESSEL HAD SHUT DOWN. INTRACORONARY NITROGLYCERIN WAS ADMINISTERED AS WELL AS INTRACORONARY NIPRIDE. THE BURR WAS REMOVED, HOWEVER ,THE PHYSICIAN ADVANCED A 1.5MM UNSPECIFIED BALLOON IN AN ATTEMPT TO REMOVE THE ROTAWIRE GUIDE WIRE WITHOUT SUCCESS. FOLLOWING ADVANCEMENT OF A NONBSC GUIDE WIRE, THE BALLOON AND ROTAWIRE GUIDE WIRE WERE REMOVED. FLOW WAS NOTED DOWN THE LAD. FURTHER ANGIOGRAPHY REVEALED THE DISSECTION BACK INTO THE AORTA, WITH 99% OBSTRUCTION AT THE ORIGIN OF THE LAD AND STAINING IN THE AORTIC ROOT, AN INTRA-AORTIC BALLOON PUMP WAS INSERTED AND THE PATIENT WAS TRANSFERRED TO SURGERY. THE PATIENT REMAINED ASYMPTOMATIC WITHOUT ANY CHEST PAIN DURING THE PROCEDURE, NO FURTHER PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS IS "STABLE AND PAIN FREE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156523 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK509

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR