BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 2034027 · Received March 30, 2011

    Report

    Report Number
    3005099803-2011-01067
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IS (B)(6). (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF CLIP BENT. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED 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 SECOND OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2011-01066 FOR THE ASSOCIATED DEVICE REPORT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION HEMOSTASIS CLIPPING DEVICES WERE USED TO TREAT A BLEED IN THE COLON DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PRONGS ON THE CLIP BENT. THE BENT CLIP RELEASED FROM THE CATHETER AND FELL INTO THE PATIENT. THE CLIP WAS NOT RETRIEVED FROM THE PATIENT AND WAS LEFT TO PASS NATURALLY. A SECOND RESOLUTION CLIP WAS USED DURING THE PROCEDURE, HOWEVER THE SAME ISSUE OCCURRED; THE PRONGS ON THE CLIP BENT. THE CLIP FELL INTO THE PATIENT AND WAS NOT RETRIEVED. THE PROCEDURE WAS COMPLETED USING ARGON PLASMA COAGULATION. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. 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 10120606C2

    Patients

    Seq Age Sex Outcome Treatment
    1