BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2020281 · Received March 16, 2011

    Report

    Report Number
    2134265-2011-00658
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 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

    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

    SAME CASE AS 2134265-2011-00659. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE DETACHMENT OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL AND MID LEFT ANTERIOR DESCENDING (LAD) AND FIRST DIAGONAL BRANCH OF THE LAD. AN ATTEMPT WAS MADE TO PERFORM IVUS WITH AN ATLANTIS SR PRO2 IVUS CATHETER, BUT IT WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN THEN EXCHANGED AN UNSPECIFIED GUIDE WIRE FOR A 330 CM FLOPPY ROTAWIRE GUIDE WIRE. SIX ABLATION PASSES WERE PERFORMED WITH A 1.5MM ROTALINK PLUS FOR 222,000 - 225,000 RPM'S FOR A LENGTH OF 8 - 10 SECONDS IN THE MAIN BRANCH OF THE LAD. THEN THE PHYSICIAN NOTICED THAT THE 1.5MM BURR WAS IN THE DIAGONAL BRANCH EVEN THOUGH THE ROTAWIRE GUIDE WIRE HAD NOT BEEN POSITIONED IN THE DIAGONAL BRANCH. IT WAS THEN DETERMINED THAT THE ROTAWIRE GUIDE WIRE WAS FRACTURED. NUMEROUS ATTEMPTS TO RETRIEVE THE DETACHED GUIDE WIRE WERE UNSUCCESSFUL. THE PATIENT WAS THEN SCHEDULED FOR BYPASS SURGERY AND THE DETACHED PORTION OF THE GUIDE WIRE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. ACCORDING TO THE PHYSICIAN, THE MID PORTION OF THE SEPARATED WIRE BECAME KINKED OR BENT WHEN THE PHYSICIAN CAUGHT THE WIRE WITH A CLAMP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention SR PRO2 IVUS CATHETER| MEDIKIT INTRODUCER SHEATH| MACH1 CMP3.0 GUIDE CATHETER| 1.5MM ROTALINK PLUS BURR