BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3243946 · Received July 23, 2013

    Report

    Report Number
    3005099803-2013-07436
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE PATIENT AGE AND DATE OF BIRTH WERE NOT REPORTED, IT WAS REPORTED THE PATIENT WAS OVER 18 YEARS OLD. (B)(4) FOR THE REPORTED EVENT OF CLIP DIFFICULT TO RELEASE FROM CATHETER. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2013-07434 ADDRESSES THE FIRST RESOLUTION CLIP DEVICE, MANUFACTURER REPORT # 3005099803-2013-07435 ADDRESSES THE SECOND RESOLUTION CLIP DEVICE AND MANUFACTURER REPORT # 3005099803-2013-07436 ADDRESSES THE THIRD RESOLUTION CLIP DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2013 THAT THREE RESOLUTION CLIP DEVICES WERE USED FOR DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST RESOLUTION CLIP WAS DEPLOYED ONTO THE TISSUE; HOWEVER, THE CLIP COULD NOT BE RELEASED FROM THE CATHETER. THE CLIP EVENTUALLY RELEASED AND FELL INTO THE PATIENT IN A CLOSED STATE. THIS OCCURRED AGAIN FOR A SECOND AND THIRD RESOLUTION CLIP. HOWEVER, THE THIRD CLIP STAYED IN PLACE ON THE TISSUE AND DID NOT FALL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE THIRD RESOLUTION CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342636 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 ML000034C2

    Patients

    Seq Age Sex Outcome Treatment
    1