BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2012344 · Received March 9, 2011

    Report

    Report Number
    2134265-2011-00665
    Event Type
    Death
    Date Received
    March 9, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROTABLATOR CATHETER UNIT AND THE RELATED ROTAWIRE WERE RETURNED. THE ROTAWIRE WAS INSERTED IN THE CATHETER DEVICE. THE DISTAL GUIDE WIRE WAS STUCK WITHIN THE COIL. THE GUIDE WIRE COULD NOT BE REMOVED FROM THE BURR. MICROSCOPIC EXAMINATION OF THE BURR IDENTIFIED A DAMAGED ANNULUS. THERE WERE NO SCRATCHES THAT EXPOSED BRASS ON THE PLATED BACK HALF OF THE BURR. NO FURTHER DAMAGE WAS NOTED ON THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR.: 2134265-2011-00666. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE AND VESSEL PERFORATION OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. THE 90% STENOSED LESION WAS LOCATED IN A NON TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX (CX) ARTERY. THE LESION WAS SUCCESSFULLY ABLATED TWICE, WITH A 2.0MM ROTALINK BURR. THEN, THE 1.5MM ROTALINK BURR WAS ADVANCED TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE ROTATIONAL SPEED OF THE BURR WAS 200,000RPMS AND DURING THE FIRST ATTEMPT TO ABLATE, THE ROTAWIRE GUIDE WIRE FRACTURED APPROXIMATELY 7CM PROXIMAL TO THE DISTAL END. THE BURR 'DISLOCATED AND MOVED INTO THE CX', PERFORATING THE VESSEL. THE BURR WAS RETRACTED AND REMOVED FROM THE PATIENT. RESUSCITATION WAS PERFORMED ON THE PATIENT. THE GUIDE WIRE WAS LEFT IN THE PATIENT AND THE PATIENT WENT TO SURGERY. DURING SURGERY THE GUIDE WIRE WAS REMOVED AND PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT EXPIRED 24 DAYS AFTER THE PROCEDURE DUE TO HYPOXIC CEREBRAL DAMAGE.

    Description of Event or Problem · 1

    SAME CASE AS MFR.: 2134265-2011-00666. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE AND VESSEL PERFORATION OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. THE 90% STENOSED LESION WAS LOCATED IN A NON TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX (CX) ARTERY. THE LESION WAS SUCCESSFULLY ABLATED TWICE, WITH A 2.0MM ROTALINK BURR. THEN, THE 1.5MM ROTALINK BURR WAS ADVANCED TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE ROTATIONAL SPEED OF THE BURR WAS 200,000RPMS AND DURING THE FIRST ATTEMPT TO ABLATE, THE ROTAWIRE GUIDE WIRE FRACTURED APPROXIMATELY 7CM PROXIMAL TO THE DISTAL END. THE BURR "DISLOCATED AND MOVED INTO THE CX", PERFORATING THE VESSEL. THE BURR WAS RETRACTED AND REMOVED FROM THE PATIENT. RESUSCITATION WAS PERFORMED ON THE PATIENT. THE GUIDE WIRE WAS LEFT IN THE PATIENT AND THE PATIENT WENT TO SURGERY. DURING SURGERY, THE GUIDE WIRE WAS REMOVED AND PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT EXPIRED 24 DAYS AFTER THE PROCEDURE DUE TO HYPOXIC CEREBRAL DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H802227680030 0012274879

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| R ROTAWIRE GUIDE WIRE