BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPULSE GUIDE CATHETER

    MDR report key: 2802768 · Received October 24, 2012

    Report

    Report Number
    2134265-2012-06722
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQO
    PMA / PMN Number
    K992142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF AN IMPULSE CATHETER WITH AN UNIDENTIFIED STENT AND GUIDEWIRE. THE GUIDEWIRE WAS IN THE LUMEN OF THE CATHETER. THERE WAS TISSUE OBSERVED ON THE STENT. THE STENT WAS ENTANGLED ON THE DISTAL END OF THE CATHETER 9 MM FROM THE DISTAL TIP. THERE WERE STENT IMPRESSIONS ON THE CATHETER. PRODUCT ANALYSIS CONFIRMED THAT A STENT WAS ATTACHED TO THE IMPULSE CATHETER. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, FOREIGN MATTER WAS OBSERVED. THE 5F IMPULSE GUIDE CATHETER WAS ADVANCED THROUGH AN UNKNOWN STENT, LOCATED IN A GRAFT OF THE OBTUSE MARGINAL TO THE AORTA, MAKING THE GUIDE CATHETER HARD TO TORQUE. WHEN THE IMPULSE GUIDE CATHETER WAS REMOVED IT HAD METAL ATTACHED TO IT. THE SOURCE OF THE METAL IS UNKNOWN, HOWEVER, THE STENT REMAINED IMPLANTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, FOREIGN MATTER WAS OBSERVED. THE 5F IMPULSE GUIDE CATHETER WAS ADVANCED THROUGH AN UNKNOWN STENT, LOCATED IN A GRAFT OF THE OBTUSE MARGINAL TO THE AORTA, MAKING THE GUIDE CATHETER HARD TO TORQUE. WHEN THE IMPULSE GUIDE CATHETER WAS REMOVED IT HAD METAL ATTACHED TO IT. THE SOURCE OF THE METAL IS UNKNOWN, HOWEVER, THE STENT REMAINED IMPLANTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPULSE GUIDE CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - MAPLE GROVE H749163913001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other