BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK? PLUS

    MDR report key: 3813165 · Received May 15, 2014

    Report

    Report Number
    2134265-2014-02654
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATED: DEVICE EVALUATED BY MFR., EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES. DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR EVALUATION. DEVICE ANALYSIS NOTED DURING VISUAL EXAMINATION THAT THE HANDSHAKE CONNECTOR OF THE CATHETER WAS BROKEN FROM THE DEVICE. THE COIL WAS ATTACHED TO THE CONNECTOR HOWEVER THE PROXIMAL COIL COULD NOT BE INSPECTED AS THE BURR COULD NOT BE PUSHED BACK INTO THE SHEATH FROM THE DISTAL END. THE CATHETER COULD NOT BE CONNECTED TO A SAMPLE ADVANCER AS THE HANDSHAKE CONNECTOR WAS NOT ATTACHED TO THE CATHETER. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE CAUSE OF THE REPORTED DIFFICULTIES MAY BE DUE INTERACTION WITH ANOTHER DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT DAMAGE OCCURRED. A 1.25MM ROTALINK PLUS WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, IT WAS NOTED THAT THE ROTABLATOR DAMAGED AN UNSPECIFIED STENT. THE PATIENT WAS SENT FOR AN EMERGENT CORONARY ARTERY BYPASS GRAFTING PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT DAMAGE OCCURRED. A 1.25MM ROTALINK PLUS WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, IT WAS NOTED THAT THE ROTABLATOR DAMAGED AN UNSPECIFIED STENT. THE PATIENT WAS SENT FOR AN EMERGENT CORONARY ARTERY BYPASS GRAFTING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291309 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310020 0016654413

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention