BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 4170498 · Received October 14, 2014

    Report

    Report Number
    2134265-2014-06123
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: INVESTIGATION COMPLETED. THE DEVICE RETURNED HAS THE DISTAL END DAMAGED. APPROXIMATELY 2.3CM SECTION OF THE DISTAL TIP WAS NOT RETURNED. VISUAL AND TACTILE INSPECTION NOTED THE DISTAL TIP DETACHED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT THE TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT CORONARY ARTERY BYPASS GRAFTING (CABG) WAS PERFORMED TO TREAT THE VESSEL PERFORATION. PATIENT CONDITION WAS GOOD AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2014-06124. IT WAS REPORTED THAT WIRE BREAKAGE AND VESSEL PERFORATION OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 325CM ROTAWIRE AND AN UNSPECIFIED SIZE ROTALINK BURR WERE USED FOR SLOW STROKE ABLATION WHERE ABLATION WAS PERFORMED 30 TIMES AT ABOUT 10 SECONDS/ABLATION WITH A TOTAL ABLATION DURATION OF 10 MINUTES. THE ROTATIONAL SPEED WAS AT 180,000 RPM. HOWEVER, IT WAS NOTED THAT THE VESSEL WAS PERFORATED AND THE ROTAWIRE SEPARATED. THE PATIENT UNDERWENT SURGERY AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2014-06124. IT WAS REPORTED THAT WIRE BREAKAGE AND VESSEL PERFORATION OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 325CM ROTAWIRE AND AN UNSPECIFIED SIZE ROTALINK BURR WERE USED FOR SLOW STROKE ABLATION WHERE ABLATION WAS PERFORMED 30 TIMES AT ABOUT 10 SECONDS/ABLATION WITH A TOTAL ABLATION DURATION OF 10 MINUTES. THE ROTATIONAL SPEED WAS AT 180,000 RPM. HOWEVER, IT WAS NOTED THAT THE VESSEL WAS PERFORATED AND THE ROTAWIRE SEPARATED. THE PATIENT UNDERWENT SURGERY AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651602 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H802228240021

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ROTALINK BURR