BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2771635 · Received October 4, 2012

    Report

    Report Number
    2134265-2012-06042
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    June 19, 2012
    Report Date
    September 10, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: ONE DEVICE WAS RECEIVED WITH A KINK ON THE BODY AND THE DISTAL TIP DAMAGED. THE VISUAL AND TACTILE INSPECTION WAS PERFORMED AND THE DEVICE PRESENTS: A KINK AT 43CM APPROX. FROM DISTAL END AND A FRACTURE AT 329.2CM APPROX. FROM DISTAL END. ALL THE OUTER DIAMETER MEASUREMENTS ARE WITHIN THE SPECIFICATIONS. THE FRACTURE SECTION WAS SENT TO THE (B)(4) LAB FOR ANALYSIS. AFTER (B)(4) LAB REPORTED THE FAILURE OCCURRED DUE TO A BENDING OVERLOAD. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2012. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE KINK OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE FLOPPY ROTAWIRE GUIDE WIRE CROSSED THE LESION. THE PHYSICIAN THEN ATTEMPTED TO LOAD A 1.75MM ROTABLATOR ROTALINK PLUS BURR ON THE GUIDE WIRE, HOWEVER NOTED THAT THE GUIDE WIRE WAS KINKED. HOWEVER, PRODUCT ANALYSIS REVEALED A GUIDE WIRE TIP FRACTURE.

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON 10SEP2012. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE KINK OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE FLOPPY ROTAWIRE GUIDE WIRE CROSSED THE LESION. THE PHYSICIAN THEN ATTEMPTED TO LOAD A 1.75MM ROTABLATOR ROTALINK PLUS BURR ON THE GUIDE WIRE, HOWEVER NOTED THAT THE GUIDE WIRE WAS KINKED. HOWEVER, PRODUCT ANALYSIS REVEALED A GUIDE WIRE TIP FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - MIAMI H802228240020 14697179

    Patients

    Seq Age Sex Outcome Treatment
    1