BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1981816 · Received February 8, 2011

    Report

    Report Number
    2134265-2011-00285
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE ADVANCER UNIT WAS ATTACHED TO A TEST CATHETER AND NO ISSUES WERE NOTED WITH THE UNIT¿S HANDSHAKE CONNECTION. A TEST GUIDE WIRE WAS INSERTED IN THE ADVANCER UNIT AND NO ISSUES WERE NOTED LOADING THE GUIDE WIRE ONTO THE DEVICE. THE ROTABLATOR ADVANCER UNIT WAS WET TESTED AND NO ISSUES WERE NOTED. THE RETURNED ADVANCER UNIT WAS WITHIN SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE BURR BECAME STUCK IN THE LESION. ACCESS OBTAINED THROUGH THE FEMORAL ARTERY. THE 90% STENOTIC, ECCENTRIC SHAPED LESION WAS LOCATED IN OVERLAPPING, PREVIOUSLY DEPLOYED UNSPECIFIED STENTS IN THE NON TORTUOUS AND SEVERELY CALCIFIED PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN FIRST ABLATED THE LESION WITH A 1.25MM AND 1.50MM ROTALINK BURR AND THEN ADVANCED THE 1.75MM ROTALINK BURR TO THE LESION. THE BURR STOPPED ROTATING AND BECAME STUCK IN THE LESION. THE BURR WAS FORCEFULLY REMOVED AND THE PATIENT EXPERIENCED CHEST PAIN WHICH WAS RELIEVED WITH MORPHINE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 1.75MM ROTALINK ADVANCER BURR AND THE DEPLOYMENT OF A 2.25X18MM STENT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE BURR BECAME STUCK IN THE LESION. ACCESS OBTAINED THROUGH THE FEMORAL ARTERY. THE 90% STENOTIC, ECCENTRIC SHAPED LESION WAS LOCATED IN OVERLAPPING, PREVIOUSLY DEPLOYED UNSPECIFIED STENTS IN THE NON TORTUOUS AND SEVERELY CALCIFIED PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN FIRST ABLATED THE LESION WITH A 1.25MM AND 1.50MM ROTALINK BURR AND THEN ADVANCED THE 1.75MM ROTALINK BURR TO THE LESION. THE BURR STOPPED ROTATING AND BECAME STUCK IN THE LESION. THE BURR WAS FORCEFULLY REMOVED AND THE PATIENT EXPERIENCED CHEST PAIN WHICH WAS RELIEVED WITH MORPHINE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 1.75MM ROTALINK ADVANCER BURR AND THE DEPLOYMENT OF A 2.25X18MM STENT. NO 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 H80222782001A0 13590356

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM, 1.25MM| ADVANCE GUIDE WIRE| GUIDE CATHETER - 6F XB 3.5| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM, 1.5MM| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM, 1.75MM