BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTAWIRE AND WIRECLIP TORQUER

    MDR report key: 11402700 · Received March 2, 2021

    Report

    Report Number
    2134265-2021-02553
    Event Type
    Injury
    Date Received
    March 2, 2021
    Date of Event
    February 10, 2021
    Report Date
    April 16, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    UDI-DI
    08714729185871
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION REVEALED THAT THE SPRING TIP AT THE DISTAL END WAS FOUND BROKEN. ONLY 329.2 CM OF GUIDEWIRE WAS RETURNED. DISTAL TIP IS MISSING. MICROSCOPIC INSPECTION PERFORMED ON SPRING TIP BREAKAGE CONFIRMED. DIMENSIONAL INSPECTION OF THE DEVICE THAT COULD BE MEASURED WAS PERFORMED AND OBSERVED THAT THE OUTER DIAMETER (OD) OF THE MEDIUM AND PROXIMAL PART OF THE DEVICE WERE WITHIN SPECIFICATIONS. HOWEVER, THE OVERALL LENGTH AND OD OF THE DISTAL PART COULD NOT BE MEASURED DUE TO DEVICE CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WIRE BROKE AND REMAINED INSIDE THE PATIENT. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATE TO SEVERELY CALCIFIED MID-PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 330CM ROTAWIRE WAS SELECTED FOR USE. UPON REMOVAL, IT WAS NOTED THAT THE WIRE WAS NOT SECURED AND LOST ITS DISTAL POSITION, AND AN ADVANCEMENT WAS NEEDED TO SECURE ITS POSITION. SUBSEQUENTLY, THE WIRE WAS PLACED DISTALLY IN A SEPTAL ARTERY AND REMOVAL WAS CONTINUED USING DYNAGLIDE MODE. DURING THE SECOND REMOVAL ATTEMPT, THE WIRE BROKE ABOUT MID TIP OF THE RADIOPAQUE PORTION (5MM FROM THE TIP), CAUSING A DISTAL EMBOLIZATION ON A DISTAL SEPTAL ARTERY. ACCORDING TO THE PHYSICIAN, THE ROTAWIRE LOOPED ITSELF INTO A SIDE SEPTAL BRANCH. THE BREAK WAS THOUGHT TO BE CAUSED BY THE WIRE BEING IN THIS COMPROMISING POSITION, IN A DISTAL SEPTAL BRANCH. ALL DEVICES WERE REMOVED AND THE CONDITION OF THE PATIENT WAS EVALUATED. IT WAS DECIDED TO LEAVE THE BROKEN DISTAL WIRE IN THE DISTAL SEPTAL ARTERY, AS REMOVAL ATTEMPT WOULD CAUSE MORE DAMAGE TO THE DELICATE SEPTAL ARTERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WIRE BROKE AND REMAINED INSIDE THE PATIENT. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATE TO SEVERELY CALCIFIED MID-PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 330CM ROTAWIRE WAS SELECTED FOR USE. UPON REMOVAL, IT WAS NOTED THAT THE WIRE WAS NOT SECURED AND LOST ITS DISTAL POSITION, AND AN ADVANCEMENT WAS NEEDED TO SECURE ITS POSITION. SUBSEQUENTLY, THE WIRE WAS PLACED DISTALLY IN A SEPTAL ARTERY AND REMOVAL WAS CONTINUED USING DYNAGLIDE MODE. DURING THE SECOND REMOVAL ATTEMPT, THE WIRE BROKE ABOUT MID TIP OF THE RADIOPAQUE PORTION (5MM FROM THE TIP), CAUSING A DISTAL EMBOLIZATION ON A DISTAL SEPTAL ARTERY. ACCORDING TO THE PHYSICIAN, THE ROTAWIRE LOOPED ITSELF INTO A SIDE SEPTAL BRANCH. THE BREAK WAS THOUGHT TO BE CAUSED BY THE WIRE BEING IN THIS COMPROMISING POSITION, IN A DISTAL SEPTAL BRANCH. ALL DEVICES WERE REMOVED AND THE CONDITION OF THE PATIENT WAS EVALUATED. IT WAS DECIDED TO LEAVE THE BROKEN DISTAL WIRE IN THE DISTAL SEPTAL ARTERY, AS REMOVAL ATTEMPT WOULD CAUSE MORE DAMAGE TO THE DELICATE SEPTAL ARTERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299291 ROTAWIRE AND WIRECLIP TORQUER CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION 3520 0023981260 08714729185871

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention