BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2032831 · Received March 29, 2011

    Report

    Report Number
    2134265-2011-01123
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2011-00869, 2134265-2011-00870, 2134265-2011-01122. IT WAS REPORTED THAT DURING A CAROTID STENTING PROCEDURE, THE PATIENT EXPERIENCED SLOW FLOW AND A STROKE. THE PROCEDURE TREATED THE 80% STENOSED, LONG TARGET LESION LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED COMMON CAROTID ARTERY TO THE INTERNAL CAROTID ARTERY. TREATMENT UTILIZED A FILTERWIRE EZ AND CONSISTED OF PRE-DIALTION WITH A 3.0X30MM STERLING BALLOON, THE PLACEMENT OF A 10X31MM CAROTID WALLSTENT AND POST DILATION WITH A 4.5X30MM STERLING BALLOON. IT WAS NOTED THAT THE VESSEL WAS "OPENED AS INTENDED" AFTER THE PROCEDURE. AFTER PLACING THE CAROTID WALLSTENT, ANGIOGRAPHY REVEALED SLOW FLOW DUE TO A PLAQUE SHIFT. THE PATIENT EXPERIENCED PROGRESSIVE YAWNING AND PALSY AFTER THE PROCEDURE AND WAS GIVEN MEDICATION. FOUR DAYS POST THE PROCEDURE, THE PATIENT'S CONDITION WORSENED AND IT WAS REPORTED THAT THE PATIENT HAD AN EXTENSIVE STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031453010 13748897

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 3.0X30MM STERLING BALLOON| CAROTID WALLSTENT 10X31| FILTERWIRE EZ