BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTAWIRE AND WIRECLIP TORQUER

    MDR report key: 11529498 · Received March 19, 2021

    Report

    Report Number
    2134265-2021-03587
    Event Type
    Death
    Date Received
    March 19, 2021
    Date of Event
    March 4, 2021
    Report Date
    March 22, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE DETACHED, AND PATIENT DEATH OCCURRED. A 330CM ROTAWIRE AND WIRECLIP TORQUER WAS SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE IN THE OSTIAL RIGHT CORONARY ARTERY (RCA) TO TREAT ANGINA PECTORIS. A BYPASS WAS USED TO RETROGRADE THE SEG.1 OF THE RCA. AFTER ABLATION WAS SUCCESSFULLY PERFORMED, THE ROTAWIRE WAS WITHDRAWN. UPON REMOVAL, IT WAS DISCOVERED THAT THE 2.2CM RADIOPAQUE TIP OF THE GUIDEWIRE REMAINED IN THE PROXIMAL PORTION OF THE VESSEL. A STENT WAS IMPLANTED TO PUSH THE DEVICE FRAGMENT INTO THE VESSEL WALL. THROMBUS FORMATION OCCURRED, AND THE PATIENT WENT INTO VENTRICULAR FIBRILLATION. CARDIAC MASSAGE WAS PERFORMED, AND THE PATIENT WAS VENTILATED AND TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT DIED ON (B)(6) 2021. IT WAS FURTHER REPORTED THAT THROMBUS FORMATION STARTED BEFORE THE STENT WAS IMPLANTED. AN ATTEMPT WAS MADE TO SNARE THE DEVICE FRAGMENT. AT THIS TIME, OCCLUSION OF THE VESSEL OCCURRED, AND THE THROMBUS FORMATION PROGRESSED TO THE DISTAL PORTION OF THE VESSEL. UNDER CPR, ANOTHER COMPLICATION OCCURRED. THE PATIENT EXPERIENCED A LIVER PARTIAL TEAR AND WENT TO EMERGENCY SURGERY. USING A NON-BOSTON SCIENTIFIC HEART PUMP AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), THE PATIENT WAS STABILIZED. THEN THE PATIENT EXPERIENCED ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) AND NEEDED LUNG VENTILATION SUPPORT, BUT THE NEXT OF KIN DID NOT WANT THAT. THE PHYSICIAN IS OF THE OPINION THAT THE ROTAWIRE WAS RELATED TO PATIENT DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE DETACHED, AND PATIENT DEATH OCCURRED. A 330CM ROTAWIRE AND WIRECLIP TORQUER WAS SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE IN THE OSTIAL RIGHT CORONARY ARTERY (RCA) TO TREAT ANGINA PECTORIS. A BYPASS WAS USED TO RETROGRADE THE SEG.1 OF THE RCA. AFTER ABLATION WAS SUCCESSFULLY PERFORMED, THE ROTAWIRE WAS WITHDRAWN. UPON REMOVAL, IT WAS DISCOVERED THAT THE 2.2CM RADIOPAQUE TIP OF THE GUIDEWIRE REMAINED IN THE PROXIMAL PORTION OF THE VESSEL. A STENT WAS IMPLANTED TO PUSH THE DEVICE FRAGMENT INTO THE VESSEL WALL. THROMBUS FORMATION OCCURRED, AND THE PATIENT WENT INTO VENTRICULAR FIBRILLATION. CARDIAC MASSAGE WAS PERFORMED, AND THE PATIENT WAS VENTILATED AND TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT DIED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424647 ROTAWIRE AND WIRECLIP TORQUER CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION 3520 0026212852 08714729185871

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R