BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 2083591 · Received May 10, 2011

    Report

    Report Number
    3005099803-2011-01537
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT 3005099803-2011-01538 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIP DEVICES WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED IN THE DUODENUM ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IN BOTH INSTANCES, WHEN AN ATTEMPT TO PLACE THE CLIPS WAS MADE, ONLY ONE SIDE OF THE CLIP WOULD CLOSE ON THE TISSUE THEREFORE, WHEN THE CLIPS WERE DEPLOYED, THEY FELL INTO THE PATIENT IN AN OPEN STATE. THE CLIPS WERE RETRIEVED. THE CASE WAS COMPLETED WITH A THIRD RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522610

    Patients

    Seq Age Sex Outcome Treatment
    1