BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR

    MDR report key: 14471312 · Received May 23, 2022

    Report

    Report Number
    3005099803-2022-02740
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    April 26, 2022
    Report Date
    June 29, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    UDI-DI
    08714729019312
    PMA / PMN Number
    K131700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED HEALTH CARE FACILITY'S ADDRESS IS (B)(6). (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE PROBLEM ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    BLOCK E1: THE REPORTED HEALTH CARE FACILITY'S ADDRESS IS 730 EZU, TOTTORI CITY, TOTTORI PREFECTURE 6800901. BLOCK H6: PROBLEM CODE A07 CAPTURES THE REPORTABLE EVENT OF SUBOPTIMAL CAUTERY. BLOCK H10: (PRODUCT INVESTIGATION): ONE CAPTIVATOR SNARE WAS RECEIVED FOR ANALYSIS. VISUAL ANALYSIS OF THE DEVICE REVEALED NO PROBLEMS HAD BEEN FOUND. FUNCTIONAL INSPECTION WAS PERFORMED AND THE DEVICE WAS ABLE TO EXTEND COMPLETELY AND RETRACT WITHOUT PROBLEMS. ELECTRICAL TEST WAS ALSO PERFORMED AND THE DEVICE'S ELECTRICAL RESISTANCE WAS WITHIN SPECIFICATION, INDICATING A PROPER CONNECTION. THE REPORTED EVENT OF "DEVICE DELIVERS ENERGY INTERMITTENTLY" COULD NOT BE CONFIRMED SINCE NO PROBLEMS WERE NOTED WITH THE ELECTRICAL DEVICE TESTING DURING ELECTRICAL RESISTANCE TEST UPON RETURN. THE PRODUCT RECORD REVIEW CONFIRMED THAT THIS IS NOT A NEW FAILURE TYPE AND THE RISK IS ANTICIPATED. THERE WAS NO EVIDENCE OF A MANUFACTURING ISSUE, DESIGN OR USER ISSUE WHICH COULD HAVE CAUSED THE COMPLAINT. DEVICE ANALYSIS FOUND NO PROBLEMS WITH THE DEVICE DURING VISUAL, FUNCTIONAL AND ELECTRICAL TEST. BASED ON THE ANALYSIS OF THE RETURNED DEVICE AND THE INFORMATION AVAILABLE, THE CODE SELECTED AS THE MOST PROBABLE CAUSE IS NO PROBLEM DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS AT THE TIME OF RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SMALL OVAL STIFF SNARE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTED THAT THERE WAS POOR ENERGIZATION. THE ACTIVE CORD WAS CONNECTED WELL AND THERE WERE SIGNS OF TISSUE BLANCHING. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SMALL OVAL STIFF SNARE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6), 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTED THAT THERE WAS POOR ENERGIZATION. THE ACTIVE CORD WAS CONNECTED WELL AND THERE WERE SIGNS OF TISSUE BLANCHING. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563839 CAPTIVATOR SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC CORPORATION M00562301 0028494739 08714729019312

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown