BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1834015 · Received September 14, 2010

    Report

    Report Number
    3005099803-2010-03846
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 22, 2010
    Report Date
    August 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE WAS DISPOSED AND IS NOT AVAILABLE FOR RETURN. BASED ON THE EVALUATION CONDUCTED AND THE DETAILS OF THE COMPLAINT, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE THIRD OF FIVE COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #'S 3005099803-2010-03845, 3005099803-2010-03896, 3005099803-2010-03847 AND 3005099803-2010-03848 FOR THE ASSOCIATED DEVICE REPORTS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 26, 2010 THAT FIVE RESOLUTION CLIP DEVICES WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2010 TO TREAT A PYLORIC TEAR. ACCORDING TO THE COMPLAINANT, DURING THE EGD PROCEDURE, THE RESOLUTION CLIP WAS ADVANCED DOWN THE ENDOSCOPE AND POSITIONED WITHIN THE PATIENT TO SEAL A PYLORIC TEAR. THE TREATMENT WAS NOT FOR AN ACTIVE BLEED. THE TECHNICIAN GRASPED TISSUE AT THE CLIPPING SITE AND LOCKED THE CLIP CLOSED; HOWEVER, THE CLIP FAILED TO RELEASE FROM THE CATHETER. DURING MANIPULATION OF THE CLIPPING DEVICE IN AN ATTEMPT TO DEPLOY THE CLIP, THE CLIP RELEASED FROM BOTH THE TISSUE AND CATHETER. THE CLOSED CLIP FELL INTO THE STOMACH. THE PHYSICIAN DID NOT ATTEMPT TO RETRIEVE THE DEVICE AND DECIDED TO LET THE CLIP PASS NATURALLY. THE SAME ISSUE WAS ENCOUNTERED WITH A TOTAL OF FIVE RESOLUTION CLIPS DURING THE PROCEDURE. ADDITIONAL RESOLUTION CLIPS WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT COMPLICATIONS. THE ENDOSCOPE WAS NOT IN A RETROFLEX POSITION AND THE DELAY IN PROCEDURE ESTIMATED TO BE APPROXIMATELY 10-15 MINUTES. 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 M00522601

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR