BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 2002996 · Received February 28, 2011

    Report

    Report Number
    3005099803-2011-00567
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    January 26, 2011
    Report Date
    February 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS LEFT INSIDE THE PATIENT TO PASS NATURALLY AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2011-00568 FOR THE ASSOCIATED DEVICE REPORT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT TWO RESOLUTION HEMOSTASIS CLIPPING DEVICES WERE USED TO TREAT A BLEED IN THE STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE EGD PROCEDURE, THE TECHNICIAN ATTEMPTED TO DEPLOY THE FIRST RESOLUTION CLIP ONTO THE TARGET TISSUE; HOWEVER, ONE OF THE PRONGS DID NOT CLOSE ONTO THE TISSUE AND BENT BACKWARDS. THE BENT CLIP RELEASED FROM THE CATHETER AND FELL INTO THE PATIENT. A SECOND RESOLUTION CLIP WAS USED, HOWEVER THE SAME ISSUE OCCURRED. THE BENT CLIP RELEASED FROM THE CATHETER AND FELL INTO THE PATIENT. BOTH DEVICES WERE NOT RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURER'S HEATER PROBE WITHOUT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE "FINE" POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 10101301C2

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR