BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2070889 · Received April 27, 2011

    Report

    Report Number
    2134265-2011-01438
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    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

    AGE AT TIME OF EVENT: 18 YEARS OF AGE OR OLDER. DEVICE EVALUATION BY MANUFACTURER: AN INITIAL EXAMINATION OF THE COMPLAINT UNIT WAS NOT CARRIED OUT AS THE PRODUCT WAS NOT RETURNED TO SITE FOR INVESTIGATION, AS THE DEVICE WAS DISPOSED OF AT THE USER FACILITY. 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/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR ID#: 2134265-2011-01604. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, BURR REMOVAL DIFFICULTIES OCCURRED. THE 90% STENOSED, 10MM LONG DE NOVO AND CONCENTRIC LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY (LAD). SIGNIFICANT ANGLES WERE NOTED PROXIMAL TO THE LESION, HOWEVER THE LESION WAS LOCATED IN A NEARLY STRAIGHT PORTION OF THE VESSEL. VASCULAR ACCESS WAS GAINED VIA THE FEMORAL ARTERY. INITIALLY, THE PHYSICIAN CROSSED THE LESION WITH A NON-BSC GUIDE WIRE. THEN THE PHYSICIAN EXCHANGED TO THE FLOPPY ROTAWIRE GUIDE WIRE. THE PHYSICIAN ATTEMPTED TO CROSS A 2.0MM ROTABLATOR ROTALINK PLUS BURR TO THE LESION, HOWEVER THE BURR COULD NOT CROSS THE LESION. THE PHYSICIAN THEN ADVANCED A NON-BSC 3.0X15MM BALLOON AND COMPLETED PREDILATION. THE PHYSICIAN THEN ADVANCED THE 1.75MM ROTABLATOR ROTALINK PLUS BURR AND 2-3 ABLATION RUNS WERE COMPLETED. HOWEVER, THE BURR "JUMPED" OVER THE TARGET LESION, AND BECAME DIFFICULT TO REMOVE. THE PHYSICIAN ROTATED THE BURR IN AN ATTEMPT TO REMOVE IT, HOWEVER THE BURR THEN STALLED. THE PATIENT WAS TAKEN TO SURGERY FOR BURR AND GUIDE WIRE REMOVAL AND CABG. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS FOLLOWING SURGERY IS LISTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310040 13860206

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BALLOON CATHETER: TAZUNA 3.0X15MM| GUIDE WIRE: RUNTHROUGH| ROTABLATOR ROTALINK PLUS 2.0MM| GUIDE WIRE: ROTAWIRE| GUIDE CATHETER: 8FR HEARTRAIL JL4