BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3013243 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01696
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: (B)(6). (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: INITIAL VISUAL EXAMINATION NOTED THAT THE STENT WAS KINKED APPROXIMATELY 20MM FROM THE TIP OF THE DEVICE. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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

    COMPLAINT IS REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING THE PREPARATION FOR A STENTING TREATMENT PROCEDURE, TIP DAMAGE WAS NOTED. THE PHYSICIAN TOOK A 2.5X28MM PROMUS ELEMENT PLUS STENT OUT OF THE HOOP, PREPPED IT AND WHEN GOING TO LOAD IT ON THE WIRE FELT THAT THE "TIP OF THE BALLOON" WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE. HOWEVER, ANALYSIS OF THE RETURNED PRODUCT REVEALED THAT THERE WAS STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116296 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911428250 15445036

    Patients

    Seq Age Sex Outcome Treatment
    1