BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1891674 · Received November 5, 2010

    Report

    Report Number
    2134265-2010-05097
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 30, 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

    (B)(6). AN INITIAL EXAMINATION OF THE COMPLAINT ROTABLATOR PLUS UNIT WAS CARRIED OUT. A (B)(6) TEST WAS PERFORMED TO EXAMINE THE INTEGRITY OF THE CONNECTION. A CONNECT/DISCONNECT TEST WAS CARRIED OUT. NO ISSUES WERE NOTED WITH THE UNIT HANDSHAKE CONNECTORS. AN ATTEMPT WAS MADE TO LOAD THE PLUS UNIT USING A CONTROL GUIDEWIRE. RESISTANCE WAS MET IN THE ANNULUS OF THE BURR. THE BURR AND COIL WERE MICROSCOPIC EXAMINED. NO ISSUE WAS NOTED WITH THE ANNULUS OF THE BURR. DRIED SALINE WAS NOTED ON THE BURR. IT WAS NOTED ON THE MICROSCOPIC EXAMINATION OF THE CATHETER DEVICE, THAT THREADS WERE ATTACHED TO THE DISTAL COIL OF THE CATHETER, APPROXIMATELY 1.0CM 3.0CM FROM THE BURR. THE COIL WAS SOAKED IN WARM WATER TO REMOVE THE DRIED SALINE. THE BURR AND COIL WERE AGAIN MICROSCOPICALLY EXAMINED. ALL SALINE DEPOSITS WERE REMOVED. AN ATTEMPT WAS MADE AGAIN TO INSERT THE GUIDEWIRE ONTO THE PLUS UNIT. RESISTANCE WAS MET IN THE DISTAL COIL OF THE CATHETER, WHERE THE THREADS AND FIBERS WERE LOCATED. 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).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY PROCEDURE, THE BURR COULD NOT BE LOADED ONTO THE ROTAWIRE. THE 75% STENOSED LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED DISTAL LEFT CIRCUMFLEX (LCX) ARTERY. THE FIRST ABLATION WITH THE 1.5MM ROTALINK PLUS WAS PERFORMED AND THE BURR WAS REMOVED FROM THE PATIENT'S BODY. WHEN IT WAS DECIDED TO PERFORM A SECOND ABLATION, THEY WERE UNABLE TO RE-LOAD THE DEVICE ONTO THE ROTAWIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. RETURNED PRODUCT ANALYSIS FOUND THAT THREADS WERE ATTACHED TO THE DISTAL COIL OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 13578766

    Patients

    Seq Age Sex Outcome Treatment
    1 ROTAWIRE GUIDE WIRE| MEDKIT INTRODUCER| RUNTHROUGH GUIDE WIRE| 6FR MACH1CLS3.5 GUIDE CATHETER| SJM INFLATION DEVICE