BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDEZILLA?

    MDR report key: 4107134 · Received September 22, 2014

    Report

    Report Number
    2134265-2014-05611
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K123765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHAFT BROKE. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL. THE TARGET LESION WAS LOCATED IN THE EXTREMELY TORTUOUS LEFT CORONARY ARTERY. A GUIDEZILLA GUIDE EXTENSION CATHETER (GEC) WAS USED AND REMOVED FROM THE PATIENT. THE SHAFT OF THE GEC PULLED APART FROM THE MAIN PORTION OF THE DEVICE, OUTSIDE THE PATIENT, IN ATTEMPT OF REMOVING FROM ANOTHER UNSPECIFIED DEVICE THAT WAS STUCK IN THE GEC. THE PROCEDURE COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586636 GUIDEZILLA? CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H7493924215050 17042281

    Patients

    Seq Age Sex Outcome Treatment
    1