BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1821046 · Received August 31, 2010

    Report

    Report Number
    3005099803-2010-03763
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Report Date
    August 4, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVISED TO REFLECT THE CHANGE IN REPORTABILITY.

    Additional Manufacturer Narrative · 1

    (B)(4): THE COMPLAINANT INDICATED THAT THE DEVICE 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A RESOLUTION CLIP DEVICE WAS USED DURING PROCEDURE TO TREAT AN ACTIVE BLEED. THE EVENT WAS INITIALLY REPORTED AS DEVICE DEFECTIVE. CLARIFICATION FROM THE COMPLAINANT REVEALED THAT THE FAILURE WAS THAT THE CLIP WOULD NOT STAY ATTACHED TO THE TISSUE AFTER IT RELEASED FROM THE CATHETER. THIS IS NOT A REPORTABLE EVENT AS THERE IS NO POTENTIAL FOR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A RESOLUTION CLIP DEVICE WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE RESOLUTION CLIP WAS DEFECTIVE AND DID NOT WORK. SEVERAL ATTEMPTS TO ASCERTAIN FURTHER DETAILS (INCLUDING PATIENT INFORMATION AND FOLLOW-UP PROCEDURE INFORMATION) HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 0ML9122106

    Patients

    Seq Age Sex Outcome Treatment
    1