BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION II CLIP

    MDR report key: 2022950 · Received March 18, 2011

    Report

    Report Number
    3005099803-2011-00877
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K102764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION II CLIP DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY ATTACHED THE CLIP TO THE TARGET SITE (AMPULLA) HOWEVER, THE CLIP WOULD NOT RELEASE FROM THE CATHETER. THE PHYSICIAN WAS ABLE TO MANIPULATE THE CLIP OFF THE MUCOSA WITH NO DAMAGE TO THE TISSUE. THE CLIP FELL INTO THE PATIENT IN A CLOSED STATE AND WAS NOT RETRIEVED. THE PHYSICIAN REPORTED THE SCOPE WAS NOT IN A RETROFLEX POSITION HOWEVER IT WAS IN A TORQUE POSITION. IT WAS ALSO REPORTED THAT THERE WAS A 1 TO 5 MINUTE DELAY DUE TO THIS EVENT. THE CASE WAS COMPLETED WITH A COMPETITOR'S 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 II CLIP HEMORRHOID LIGATOR MND BOSTON SCIENTIFIC - MARLBOROUGH M00522511 1ML1010605

    Patients

    Seq Age Sex Outcome Treatment
    1