BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? ADVANCER

    MDR report key: 3770681 · Received April 24, 2014

    Report

    Report Number
    2134265-2014-02240
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    December 24, 2013
    Report Date
    March 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE WAS RECEIVED FOR ANALYSIS. IT WAS OBSERVED THAT THE BRAKE OF THE ADVANCER WAS NOT ATTACHED TO THE RETURNED DEVICE INDICATING A RESISTANCE WAS MET. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2014. IT WAS REPORTED THAT A GUIDE WIRE JAMMED. A ROTALINK ADVANCER AND 330CM ROTAWIRE WERE SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING PROCEDURE, IT WAS NOTED THAT THE ROTAWIRE JAMMED IN THE ADVANCER AND AN UNUSUAL NOISE WERE OBSERVED. IT WAS FURTHER NOTED THAT THE ROTAWIRE WAS KINKED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AT THE TIME OF THE EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE BRAKE OF THE ADVANCER WAS NOT ATTACHED TO THE RETURNED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248467 ROTALINK? ADVANCER CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H80222782001A0 0016476765

    Patients

    Seq Age Sex Outcome Treatment
    1 ROTA WIRE: GUIDE WIRE