BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION¿

    MDR report key: 2863190 · Received December 10, 2012

    Report

    Report Number
    2134265-2012-07353
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    September 18, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED. THE BALLOON WAS TIGHTLY FOLDED, WHICH INDICATES NO SIGN OF INFLATION PRESSURE. THE STENT WAS CENTERED BETWEEN THE MARKERBANDS. THE DISTAL END OF THE STENT STRUTS WERE BENT. THE TIP WAS FLARED. MAGNIFIED INSPECTION REVEALED NO DAMAGE OR IRREGULARITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INSERTION DIFFICULTIES OR THE STENT AND TIP DAMAGE. THE REPORTED INSERTION DIFFICULTIES COULD NOT BE CONFIRMED. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(4) 2012. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING PROCEDURE DIFFICULTY ADVANCING OCCURRED. THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 4.0X20MM ION STENT IN AN UNSPECIFIED LESION WHEN IT BECAME HOOKED ON THE NON-BSC GUIDE CATHETER AN NEVER PASSED THROUGH THE CATHETER. THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED WITH ANOTHER ION STENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS IS STABLE HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902420400 14373355

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR