BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION II CLIP

    MDR report key: 2070199 · Received April 27, 2011

    Report

    Report Number
    3005099803-2011-01421
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K102764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE HANDLE WAS KINKED AT THE LOCKS, WHICH WOULD PREVENT THE CLIP FROM BEING DEPLOYED. THE CLIP ASSEMBLY WAS STILL ABLE TO OPENED AND CLOSED, BUT THE DEVICE STROKE WAS LIMITED. NO DAMAGE TO THE CLIP ASSEMBLY WAS NOTED. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE CLIP FAILED TO RELEASE FROM THE CATHETER. HOWEVER, THE EVALUATION ATTRIBUTED THIS FAILURE TO A BROKEN HANDLE. NO DAMAGE TO THE CLIP ASSEMBLY WAS VISIBLE. THE FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMANCE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Additional Manufacturer Narrative · 1

    NOTE FOR CLARIFICATION: THE DEVICE EVALUATION REVEALED THAT THE HANDLE WAS KINKED AT THE LOCKS. THIS FAILURE ALLOWED THE CLIP TO OPEN AND CLOSE, BUT PREVENTED THE CLIP FROM LOCKING CLOSED. A CLIP THAT CANNOT LOCK COULD BE OPENED FOR RELEASE FROM THE PATIENT'S TISSUE. THIS IS A DIFFERENT FAILURE MODE THEN A CLIP THAT LOCKS CLOSED, BUT FAILS TO SEPARATE FROM THE DELIVERY CATHETER. THEREFORE, BASED ON THE DEVICE EVALUATION AND THE PHYSICIAN'S REPORT THAT THE CLIP WAS ABLE TO BE OPENED PRIOR TO REMOVAL FROM THE TISSUE, THIS IS NO LONGER CONSIDERED A MDR REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    THE PATIENT WEIGHT HAS BEEN REPORTED TO BE APPROXIMATELY (B)(6). (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF CLIP FAILED TO RELEASE FROM THE CATHETER. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION II CLIP DEVICE WAS USED DURING A COLONOSCOPY WITH POLYPECTOMY, AS A PROPHYLACTIC MEASURE, PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WAS CLOSED ONTO THE TARGET SITE HOWEVER, THE CLIP WOULD NOT RELEASE FROM THE CATHETER. THE PHYSICIAN OPENED THE CLIP BACK UP AND PLACED IT ON THE TARGET SITE AGAIN HOWEVER, THE CLIP WOULD NOT RELEASE FROM THE CATHETER. IT WAS REPORTED THAT THE PHYSICIAN OBSERVED THAT THE CLIP APPEARED TO BE BROKEN. THE CLIP WAS THEN REOPENED, CLOSED AND THE DEVICE WAS REMOVED FROM THE PATIENT COMPLETELY INTACT. THE CASE WAS COMPLETED WITH ANOTHER RESOLUTION II CLIP DEVICE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION II CLIP DEVICE WAS USED DURING A COLONOSCOPY WITH POLYPECTOMY, AS A PROPHYLACTIC MEASURE, PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WAS CLOSED ONTO THE TARGET SITE HOWEVER, THE CLIP WOULD NOT RELEASE FROM THE CATHETER. THE PHYSICIAN OPENED THE CLIP BACK UP AND PLACED IT ON THE TARGET SITE AGAIN HOWEVER, THE CLIP WOULD NOT RELEASE FROM THE CATHETER. IT WAS REPORTED THAT THE PHYSICIAN OBSERVED THAT THE CLIP APPEARED TO BE BROKEN. THE CLIP WAS THEN REOPENED, CLOSED AND THE DEVICE WAS REMOVED FROM THE PATIENT COMPLETELY INTACT. THE CASE WAS COMPLETED WITH ANOTHER RESOLUTION II CLIP DEVICE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION II CLIP DEVICE WAS USED DURING A COLONOSCOPY WITH POLYPECTOMY, AS A PROPHYLACTIC MEASURE, PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WAS CLOSED ONTO THE TARGET SITE HOWEVER, THE CLIP WOULD NOT RELEASE FROM THE CATHETER. THE PHYSICIAN OPENED THE CLIP BACK UP AND PLACED IT ON THE TARGET SITE AGAIN HOWEVER, THE CLIP WOULD NOT RELEASE FROM THE CATHETER. IT WAS REPORTED THAT THE PHYSICIAN OBSERVED THAT THE CLIP APPEARED TO BE BROKEN. THE CLIP WAS THEN REOPENED, CLOSED AND THE DEVICE WAS REMOVED FROM THE PATIENT COMPLETELY INTACT. THE CASE WAS COMPLETED WITH ANOTHER RESOLUTION II CLIP DEVICE. 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 II CLIP LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522512 1ML1020201

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR