BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDEZILLA¿

    MDR report key: 7116824 · Received December 14, 2017

    Report

    Report Number
    2134265-2017-12428
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    October 30, 2017
    Report Date
    December 1, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K123765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. RETURNED PRODUCT CONSISTED OF A GUIDEZILLA GUIDE EXTENSION CATHETER IN TWO PIECES. THE TIP, DISTAL SHAFT, COLLAR AND HYPOTUBE WAS MICROSCOPICALLY AND TACTILE INSPECTED. INSPECTION REVEALED A COMPLETE SEPARATION AT THE COLLAR, WITH A KINK IN THE HYPOTUBE LOCATED 21 CM FROM THE STRAIN RELIEF, KINKS IN THE DISTAL SHAFT LOCATED 6.5 CM AND 10 CM FROM THE TIP, AND DAMAGE TO THE TIP. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY DAMAGE OR IRREGULARITIES CONTRIBUTING TO THE REPORTED CROSSING DIFFICULTY, WHICH COULD NOT BE CONFIRMED BECAUSE THE CLINICAL CIRCUMSTANCES COULD NOT BE REPLICATED. THE INVESTIGATION CONCLUSION IS OPERATIONAL CONTEXT AS THE PRODUCT MEETS THE DESIGN & MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED.BSC ID: A00683322TW#: 4853687

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2017. IT WAS REPORTED THAT DIFFICULTY CROSSING LESION OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED MID LEFT CIRCUMFLEX ARTERY. A GUIDEZILLA¿ GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDEZILLA WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A COMPLETE SEPARATION OF THE COLLAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895936 GUIDEZILLA¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H7493924215050 20894819

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR