BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2453861 · Received February 15, 2012

    Report

    Report Number
    3005099803-2012-00583
    Event Type
    Injury
    Date Received
    February 15, 2012
    Date of Event
    January 30, 2012
    Report Date
    January 30, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS HOWEVER, AN EVALUATION HAS NOT BEEN PERFORMED AS OF YET. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION FOUND THAT THE DEVICE RETURNED WITH THE CLIP ASSEMBLY LOCATED JUST INSIDE THE OVERSHEATH. ONCE THE OVERSHEATH WAS PULLED BACK USING THE SHEATH GRIP, THE CLIP ASSEMBLY WAS ACTUATED AND DEPLOYED; TWO DISTINCTIVE CLICKS WERE HEARD. ADDITIONALLY, A KINK WAS PRESENT IN THE CONTROL WIRE. THE REPORTED EVENT OF CLIP FAILED TO RELEASE FROM THE DELIVERY CATHETER WAS NOT ABLE TO BE CONFIRMED. THE EVALUATION FOUND THAT THE CLIP WAS ABLE TO BE EXPOSED, ACTUATED, AND DEPLOYED PER DESIGN. HOWEVER, THE EVENT MAY HAVE OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMANCE AS EVIDENCED BY THE KINK PRESENT IN THE CONTROL WIRE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF SEVEN DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2012-00577, 3005099803-2012-000578, 3005099803-2012-000579, 3005099803-2012-000580, 3005099803-2012-000581, 3005099803-2012-000582, AND 3005099803-2012-000583 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SEVEN RESOLUTION CLIPS WERE USED POST POLYPECTOMY DURING A GASTROSCOPY PROCEDURE AT THE PYLORUS. ACCORDING TO THE COMPLAINANT, A BLEED DEVELOPED AFTER REMOVING A BROAD-BASED POLYP IN THE DUODENUM. A RESOLUTION CLIP WAS POSITIONED AND LOCKED ONTO THE TARGET SITE; HOWEVER, WHEN DEPLOYED, THE CLIP FAILED TO RELEASE FROM THE DELIVERY CATHETER. THE PHYSICIAN PULLED THE CLIP FROM THE SITE, WHICH LED TO TORN TISSUE AND ADDITIONAL BLEEDING. SUBSEQUENTLY, THE NEXT SIX CLIPS EXPERIENCED THE SAME ISSUE; UPON DEPLOYMENT, EACH CLIP FAILED TO RELEASE FROM THE DELIVERY CATHETER. IN EACH CASE, REMOVING THE CLIP FROM THE TISSUE LED TO ADDITIONAL BLEEDING. ADDITIONALLY, WHILE WITHDRAWING THE DEVICES, TWO HAD THEIR CLIPS DETACH WITHIN THE WORKING CHANNEL AND WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT MANUFACTURER'S DEVICE. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT WAS HOSPITALIZED AND EXAMINED FOLLOWING A DROP IN THEIR HEMOGLOBIN VALUE, BUT FOUND TO BE STABLE. THE PATIENT HAS SINCE FULLY RECOVERED AND THEIR CURRENT CONDITION WAS REPORTED AS BEING FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PATIENT RETURNED TO THE PRACTICE FOR A CONTROLLED GASTROSCOPY. ADDITIONALLY, A LAB TEST WAS PERFORMED WHICH VERIFIED THAT THE PATIENT'S HEMOGLOBIN (HB) WAS STABLE. THE PATIENT WAS NOT HOSPITALIZED. NO FURTHER COMPLICATIONS OCCURRED OR REEXAMINATIONS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 ML000126C2

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R