BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR?

    MDR report key: 4062541 · Received September 5, 2014

    Report

    Report Number
    3005099803-2014-03034
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Report Date
    August 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS OF FLARE DETACHED. INVESTIGATION RESULTS: VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE FLARE WAS DETACHED. THE CATHETER AND THE WIRE WERE ALSO FOUND TO BE KINKED. THE DEVICE HAS EVIDENCE OF THE FLARE MANUFACTURING PROCESS. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE FLARE DETACHMENT. THE FLARE BEING DETACHED WAS CONTRARY TO WHAT WAS ORIGINALLY REPORTED. GIVEN THE EVENT DESCRIPTION AND THE CONDITION OF THE RETURNED DEVICE, THERE ISN'T ENOUGH INFORMATION TO CONCLUDE A PROBABLE ROOT CAUSE. THERE IS AN INVESTIGATION IN PLACE TO ADDRESS FLARE DETACHMENT ISSUES. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM HEXAGONAL SNARE WAS USED IN A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SNARE NEVER OPENED WHILE INSIDE THE PATIENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THE FLARE DETACHED, THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545180 CAPTIVATOR? SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562340 16725684

    Patients

    Seq Age Sex Outcome Treatment
    1