BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3221234 · Received July 11, 2013

    Report

    Report Number
    2134265-2013-04920
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    April 25, 2013
    Report Date
    June 13, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED IN TWO PIECES AS RESULT OF A BREAK 685MM DISTAL TO THE STRAIN RELIEF. SEVERAL KINKS WERE NOTED AT 230MM, 400MM AND 610MM DISTAL TO THE STRAIN RELIEF, A SECOND KINK WAS NOTED 500MM PROXIMAL TO THE TIP. THE TIP OF THE DEVICE WAS DAMAGED (JAGGED EDGES). THE BALLOON AND THE STENT OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO ANY POSITIVE PRESSURE. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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 PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING PREPARATION FOR A DILATATION OF THE LESION, CATHETER SHAFT KINK OCCURRED. WHILE UNPACKING A 2.25X28MM PROMUS ELEMENT PLUS DRUG ELUTING STENT IT WAS NOTED THAT THE CATHETER SHAFT KINKED ABOUT 50CM FROM THE PROXIMAL PART WHEN THE DEVICE WAS REMOVED FROM THE HOOP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD. HOWEVER, UPON DEVICE ANALYSIS, IT WAS NOTED THAT THE HYPOTUBE WAS BROKEN AT 685MM DISTAL TO THE STRAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319680 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918428220 15774267

    Patients

    Seq Age Sex Outcome Treatment
    1