BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3172431 · Received June 17, 2013

    Report

    Report Number
    3005099803-2013-04904
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 TEN RESOLUTION CLIP DEVICE COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBERS 3005099803-2013-04898, 3005099803-2013-04899, 3005099803-2013-04900, 3005099803-2013-04901, 3005099803-2013-04902, 3005099803-2013-04903, 3005099803-2013-04904, 3005099803-2013-04905, 3005099803-2013-04906, AND 3005099803-2013-04907 FOR EACH OF THE RESPECTIVE DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT TEN RESOLUTION CLIP DEVICES WERE ATTEMPTED TO BE USED TO CLOSE A FISTULA NEAR THE SPLENIC FLEXURE DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS IN THE INTENSIVE CARE UNIT. DURING THE PROCEDURE, A RESOLUTION CLIP WAS DEPLOYED ONTO THE FISTULA; HOWEVER, THE CLIP WAS DIFFICULT TO RELEASE FROM THE CATHETER. AFTER FURTHER MANIPULATION, THE CLIP WAS ABLE TO BE RELEASED FROM THE CATHETER, BUT SUBSEQUENTLY FELL OFF THE TISSUE AND INTO THE PATIENT. THE CLIP WAS LEFT TO PASS NATURALLY. NO DAMAGE WAS NOTED TO THE TISSUE. THIS SAME ISSUE OCCURRED FOR A TOTAL OF TEN RESOLUTION CLIP DEVICES. ACCORDING TO THE PHYSICIAN, THE SCOPE WAS IN A RETROFLEXED POSITION AND THE OVERSHEATHS HAD BEEN REMOVED FROM THE DEVICES PRIOR TO USE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THREE RESOLUTION CLIP DEVICES. 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 AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272910 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522612 ML000465C3

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR