BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR GUIDE WIRE

    MDR report key: 1062511 · Received June 18, 2008

    Report

    Report Number
    2134265-2008-01704
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE GUIDE WIRE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME EVENT AS MFR REPORT #: 2134265-2008-01705. IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A WIRE DETACHMENT AND DISSECTION OCCURRED. THE PT PRESENTED WITH VENTRICULAR FIBRILLATION. THE LESION BEING TREATED WAS LOCATED IN THE TOTALLY OCCLUDED RIGHT CORONARY ARTERY (RCA). ABLATION WAS PERFORMED SUCCESSFULLY WITH THE ROTALINK PLUS SYSTEM, AND FOLLOWING REMOVAL OF THE SYSTEM THE PHYSICIAN NOTED A DISSECTION. UPON EXAMINATION OF THE DISSECTION, A FOREIGN BODY WAS ALSO VISUALIZED, AND IT WAS DETERMINED TO BE THE DISTAL TIP OF THE ROTAWIRE GUIDE WIRE. THE PHYSICIAN THEN PLACED AN UNSPECIFIED STENT WHICH BOTH COVERED THE DISSECTION AND SECURED THE GUIDE WIRE FRAGMENT AGAINST THE INTIMAL WALL OF THE ARTERY. THE RCA WAS PATENT FOLLOWING THE ABLATION AND STENTING. PRESSURES REMAINED THE SAME BEFORE AND AFTER ABLATION/STENTING. THE PT NEVER RECOVERED FROM V-FIB, AND DIED ON THE TABLE SEVERAL HOURS LATER DESPITE EFFORTS TO REVIVE HIM. THE PHYSICIAN STATED THAT THERE WAS NO RELATIONSHIP BETWEEN THE ABLATION/WIRE TIP SEPARATION AND THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR GUIDE WIRE MCX CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC FLOPPY RTW 8653564

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Required Intervention