BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1811714 · Received August 23, 2010

    Report

    Report Number
    2134265-2010-03647
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    June 23, 2010
    Report Date
    July 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE PLUS UNIT WAS RETURNED TO SITE CONNECTED TOGETHER. BLOOD WAS NOTED WITHIN THE RETURNED CATHETER SHEATH. AN ATTEMPT WAS MADE TO WIRE GUIDE THE RETURNED UNIT. RESISTANCE WAS MET IN THE DISTAL END OF THE COIL APPROXIMATELY WHERE BLOOD WAS NOTED WITHIN THE SHEATH. AN ATTEMPT WAS MADE TO WET TEST THE ROTABLATOR PLUS UNIT. THE PIN-HOLE ON THE SHEATH WAS 20 CM FROM THE STRAIN RELIEF. THE BURR WAS MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THE ANNULUS OF THE BURR. A SCRATCH TEST WAS PERFORMED TO CONFIRM IF THE RETURNED BURRS CUTTING ACTION WAS ACCEPTABLE. THIS CONFIRMED THAT THE BURRS CUTTING ACTION WAS ACCEPTABLE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS USER ERROR. THE ROTABLATOR DFU STATES THAT 'IF THE HEMEOSTASIS VALVE IS TIGHTENED EXCESSIVELY, IT CAN CRUSH THE SHEATH AROUND THE DRIVE SHAFT AND CAUSE PERMANENT DAMAGE TO THE ROTALINK CATHETER. THE HEMEOSTASIS VALVE SHOULD BE CLOSED JUST TIGHT ENOUGH TO PREVENT BLOOD LOSS, BUT STILL ALLOW THE ROTALINK SHEATH TO SLIDE THROUGH THE VALVE'. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THERE WAS DIFFICULTY ADVANCING THE BURR OVER THE WIRE. THE 1.5MM ROTALINK PLUS WAS ADVANCED OVER THE ROTAWIRE GUIDEWIRE, BUT AFTER IT WAS ADVANCED ABOUT 90CM, IT COULD NOT BE ADVANCED ANY FURTHER. THE PHYSICIAN REMOVED THE BURR AND ROTAWIRE EXAMINED IT. THERE APPEARED TO BE NO DAMAGE TO EITHER, SO HE REPEATED THE BURR ADVANCEMENT OVER THE WIRE, WITH STILL NO SUCCESS. A NEW 1.5MM ROTALINK PLUS WAS OPENED AND THEY WERE ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. UPON RETURNED DEVICE ANALYSIS, A PIN-HOLE LEAK OF THE BURR CATHETER SHEATH WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 0013310820

    Patients

    Seq Age Sex Outcome Treatment
    1 ROTAWIRE