BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 2052245 · Received April 12, 2011

    Report

    Report Number
    3005099803-2011-01126
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IS (B)(6). (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF CLIP FAILED TO RELEASE FROM CATHETER. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. 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 AND FUNCTIONAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE CLIP WAS HALF DEPLOYED, AS THE YOKE WAS STILL ATTACHED TO THE CONTROL WIRE, AND THE CLIP ASSEMBLY WAS NOT RETURNED. THE YOKE WAS ACTUATED AND DEPLOYED. IT WAS ALSO NOTICED THAT THE SHEATH GRIP WAS DETACHED FROM THE OVER SHEATH. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. BASED ON THE EVALUATION CONDUCTED AND THE DETAILS OF THE COMPLAINT, IT IS PROBABLE THAT THE FAILURE OF THE CLIP TO RELEASE FROM THE CATHETER WAS DUE TO ANATOMICAL OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE; THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-01126 AND 3005099803-2011-01130 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION HEMOSTASIS CLIPPING DEVICES WERE USED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST RESOLUTION CLIP CLOSED ONTO THE TARGET TISSUE, BUT WOULD NOT RELEASE FROM THE CATHETER. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. A SECOND RESOLUTION CLIP (MANUFACTURER REPORT # 3005099803-2011-01130) WAS THEN USED, BUT THE ISSUE RECURRED; THE CLIP CLOSED ONTO THE TARGET TISSUE, BUT FAILED TO RELEASE FROM THE CATHETER. THE DEVICE WAS REMOVED FROM THE PATIENT AND ANOTHER RESOLUTION CLIP WAS USED TO COMPLETE THE PROCEDURE. 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-01126 AND 3005099803-2011-01130 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION HEMOSTASIS CLIPPING DEVICES WERE USED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST RESOLUTION CLIP (MANUFACTURER REPORT # 3005099803-2011-01126) CLOSED ONTO THE TARGET TISSUE, BUT WOULD NOT RELEASE FROM THE CATHETER. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. A SECOND RESOLUTION CLIP (MANUFACTURER REPORT # 3005099803-2011-01130) WAS THEN USED, BUT THE ISSUE RECURRED; THE CLIP CLOSED ONTO THE TARGET TISSUE, BUT FAILED TO RELEASE FROM THE CATHETER. THE DEVICE WAS REMOVED FROM THE PATIENT AND ANOTHER RESOLUTION CLIP WAS USED TO COMPLETE THE PROCEDURE. 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522610 10092407C2

    Patients

    Seq Age Sex Outcome Treatment
    1