BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1911795 · Received December 1, 2010

    Report

    Report Number
    3005099803-2010-05001
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION UNKNOWN. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. 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

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT 3005099803-2010-05002 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIP DEVICES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IN BOTH INSTANCES, THE CLIP WAS INSERTED INTO THE ENDOSCOPE TO TREAT AN ACTIVE BLEED WITHIN THE DUODENUM HOWEVER, THE NURSE EXPERIENCED RESISTANCE WHILE PASSING THE CLIPPING DEVICE THROUGH THE WORKING CHANNEL. IT WAS REPORTED THAT THE SCOPE WAS IN A RETROFLEX POSITION. WHEN THE CLIP WAS ADVANCED FROM THE END OF THE SCOPE, IT WAS NOTICED THAT THE CLIP WAS BENT SIDEWAYS OFF THE END OF THE CATHETER. THE CLIP DID NOT FALL OFF OF THE CATHETER. THE ENTIRE CLIPPING DEVICE WAS REMOVED FROM THE PATIENT. THE PHYSICIAN THEN STRAIGHTENED THE ENDOSCOPE AND A THIRD RESOLUTION CLIP WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE DELAY IN PROCEDURE DUE TO THE TWO RESOLUTION CLIPS WAS ESTIMATED TO BE 2 MINUTES. THIS DELAY DID NOT EXACERBATE THE BLEED. 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 HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR