BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 2071035 · Received April 27, 2011

    Report

    Report Number
    3005099803-2011-01552
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE CLIP ASSEMBLY WAS DEPLOYED AND WAS NOT RETURNED. IT WAS ALSO NOTICED THAT THE OVER SHEATH AND SHEATH GRIP WERE MISSING. THE REPORTED EVENT OF CLIP FAILED TO RELEASE AND DEFECTIVE/MALFUNCTIONED/FAILED (PUNCTURE OF THE OUTER SHEATH) WAS NOT ABLE TO BE CONFIRMED DUE TO THE CLIP ASSEMBLY AND SHEATH NOT BEING RETURNED. HOWEVER, 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

    PATIENT WEIGHT IS NOT AVAILABLE. (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF CLIP FAILED TO RELEASE. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT 3005099803-2011-01553 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIP DEVICES WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST CLIP WAS ATTACHED TO THE TISSUE HOWEVER; THE CLIP HAD PUNCTURED THE OUTER SHEATH PREVENTING THE CLIP FROM RELEASING. A CYTOLOGY BRUSH WAS USED TO MANIPULATE THE CLIP OUT FROM THE SHEATH. THE CLIP REMAINED ON THE TISSUE. THE SECOND CLIP WAS ATTACHED TO THE TISSUE HOWEVER, THE CLIP WOULD NOT RELEASE FROM THE CATHETER. THE PHYSICIAN MANIPULATED THE CLIP UNTIL IT RELEASED FROM THE DELIVERY CATHETER. THE CLIP REMAINED ON THE TISSUE. IT WAS REPORTED THAT THE PATIENT WAS BLEEDING PRIOR TO THE PROCEDURE AND THAT THERE WAS NO DAMAGE TO THE TISSUE OR ANY INCREASED BLEEDING. THE CASE WAS COMPLETED WITH A THIRD RESOLUTION 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. A SECOND COMPLAINT (MANUFACTURER REPORT # 3005099803-2011-01553) WAS OPENED AGAINST A RESOLUTION CLIP DEVICE AFTER RECEIVING FOLLOW-UP INFORMATION ON (B)(6) 2011 WHICH REVEALED THAT A SECOND CLIP WAS INVOLVED WITH THIS EVENT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT 3005099803-2011-01553 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIP DEVICES WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST CLIP WAS ATTACHED TO THE TISSUE HOWEVER; THE CLIP HAD PUNCTURED THE OUTER SHEATH PREVENTING THE CLIP FROM RELEASING. A CYTOLOGY BRUSH WAS USED TO MANIPULATE THE CLIP OUT FROM THE SHEATH. THE CLIP REMAINED ON THE TISSUE. THE SECOND CLIP WAS ATTACHED TO THE TISSUE HOWEVER, THE CLIP WOULD NOT RELEASE FROM THE CATHETER. THE PHYSICIAN MANIPULATED THE CLIP UNTIL IT RELEASED FROM THE DELIVERY CATHETER. THE CLIP REMAINED ON THE TISSUE. IT WAS REPORTED THAT THE PATIENT WAS BLEEDING PRIOR TO THE PROCEDURE AND THAT THERE WAS NO DAMAGE TO THE TISSUE OR ANY INCREASED BLEEDING. THE CASE WAS COMPLETED WITH A THIRD RESOLUTION 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 HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 10120603C2

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR