BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2111874 · Received June 2, 2011

    Report

    Report Number
    2134265-2011-02116
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 6, 2011
    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

    (B)(4). 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. 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

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A BURR BECAME STUCK IN THE LESION. THE 99% STENOSED LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). A 1.25MM ROTALINK PLUS UNIT WAS INITIALLY USED TO ABLATE THE DISTAL RCA. THIS WAS EXCHANGED FOR A 1.5MM ROTALINK PLUS UNIT. DURING THE FIRST ABLATION, THE BURR BECAME STUCK IN THE LESION. ACCORDING TO THE PHYSICIAN, THERE WAS NO RESISTANCE DURING THE ABLATION PROCEDURE. THE PHYSICIAN THEN INSERTED AN ADDITIONAL GUIDE WIRE AND BALLOON, HOWEVER THE BALLOON WAS UNABLE TO REACH THE LOCATION OF THE BURR. THE BALLOON WAS ABLE TO MAKE IT TO THE MID RCA, AND A BALLOON INFLATION WAS PERFORMED, BUT THIS DID NOT RELEASE THE STUCK BURR. THE PATIENT WAS THEN TAKEN TO SURGERY TO HAVE THE DEVICE SURGICALLY RETRIEVED AND CORONARY ARTERY BYPASS GRAFTING PERFORMED. THE PATIENT'S CONDITION POST SURGERY WAS STABLE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 13775095

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1.25MM ROTALINK PLUS