BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTION II CLIP

    MDR report key: 2231802 · Received September 1, 2011

    Report

    Report Number
    3005099803-2011-02964
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 6, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K102764
    Removal / Correction Number
    REFER TO BLOCK H10.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):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 ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #'S 3005099803-2011-02963 AND 3005099803-2011-02964 ADDRESS THE TWO DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION II CLIP DEVICES WERE BEING USED TO TREAT A BLEEDING DUODENAL LESION DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST RESOLUTION II CLIP DEVICE (MANUFACTURER REPORT # 3005099803-2011-02963) GRASPED TISSUE; HOWEVER, UPON DEPLOYMENT, THE CLIP WOULD NOT RELEASE FROM THE DELIVERY SYSTEM. THE CLIP WAS PULLED AWAY FROM THE TISSUE, WHICH LED TO MINOR TEARING AND ADDITIONAL BLEEDING, AND THEN WITHDRAWN. A SECOND RESOLUTION II CLIP DEVICE (MANUFACTURER REPORT # 3005099803-2011-02964) WAS ADVANCED AND DEPLOYED, BUT THE SAME ISSUE RECURRED; THE CLIP WOULD NOT RELEASE FROM THE DELIVERY SYSTEM. ONCE AGAIN, WHEN THIS CLIP WAS PULLED AWAY FROM THE TISSUE, MINOR TEARING AND ADDITIONAL BLEEDING WERE OBSERVED. SUBSEQUENTLY, A RESOLUTION I CLIP WAS ADVANCED TO THE TARGET SITE, AND THEN SUCCESSFULLY RELEASED. REPORTEDLY, THE PHYSICIAN WAS INITIALLY UNAWARE THAT THE LESION BEING TREATED WAS A DUODENAL VARIX SO SODIUM MORRHUATE WAS INJECTED AT THE SITE TO AID WITH HEMOSTASIS. THE INJECTION DID STOP THE BLEED, HOWEVER, PER THE PHYSICIAN "THE SODIUM MORRHUATE CAUSED AN EMBOLISM IN THE LUNG AND SPLEEN." ULTIMATELY, THE PATIENT WAS ADMITTED INTO THE INTENSIVE CARE UNIT (ICU), BUT HAS SINCE BEEN RELEASED. ADDITIONALLY, THE PATIENT'S CURRENT CONDITION WAS REPORTED AS BEING OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION II CLIP LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522511 1ML1020203

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention