BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3101798 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03285
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THIS DEVICE WAS RETURNED WITH THE GUIDEWIRE. THE DISTAL END OF THE GUIDEWIRE WAS SEVERELY DAMAGED. THE COIL COVERING THE GUIDEWIRE AT THE END WAS UNRAVELLED AND HAD COME OFF THE CORE WIRE. PART OF THIS COIL HAD DETACHED AND REMAINED LODGED INSIDE THE CATHETER EXITING FROM THE GUIDEWIRE EXIT PORT. THE PORT WAS SLIGHTLY DAMAGED. THE BALLOON WAS PARTIALLY INFLATED FILLED WITH SOLIDIFIED CONTRAST MEDIA. A GUIDEWIRE COULD BE INSERTED THROUGH THE TIP AND BALLOON OF THE DEVICE; HOWEVER, IT COULD NOT BE ADVANCED FURTHER AS IT MET AN OBSTRUCTION AT APPROXIMATELY 7 CM FROM THE TIP. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CAUSED BY OTHER DEVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED. AFTER DEPLOYMENT OF A 2.25 X 24MM PROMUS ELEMENT PLUS STENT, THERE WAS RESISTANCE WITH THE NON-BSC GUIDEWIRE UPON ATTEMPTING TO REMOVE THE STENT DELIVERY SYSTEM. THE DEVICE AND THE GUIDEWIRE WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED. AFTER DEPLOYMENT OF A 2.25 X 24MM PROMUS ELEMENT PLUS STENT, THERE WAS RESISTANCE WITH THE NON-BSC GUIDEWIRE UPON ATTEMPTING TO REMOVE THE STENT DELIVERY SYSTEM. THE DEVICE AND THE GUIDEWIRE WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204113 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918424220 0015832235

    Patients

    Seq Age Sex Outcome Treatment
    1