BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2992058 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01304
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED 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. 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).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2013-01305. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY PROCEDURE, GUIDE WIRE FRACTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS DISTAL LEFT CIRCUMFLEX (LCX). THE PHYSICIAN ADVANCED A FLOPPY GOLD ROTAWIRE GUIDE WIRE TO THE LESION. A ROTABLATOR ROTALINK PLUS BURR WAS ADVANCED OVER THE GUIDE WIRE AND ABLATION WAS PERFORMED TWICE FOR TEN SECONDS AT 200,000 PM. DURING ABLATION THE GUIDE WIRE FRACTURED IN THE PROXIMAL LCX. THE PHYSICIAN ADVANCED AN UNSPECIFIED SNARE TO THE LCX AND THE FRAGMENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97731 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK UNK376

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention