BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE

    MDR report key: 2891058 · Received December 31, 2012

    Report

    Report Number
    3005099803-2012-06297
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K955869
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE UNIT COMPONENTS WERE VISUALLY EXAMINED FOR ANY DAMAGE OR DEFECT AND A YELLOW STOPCOCK WAS RETURNED CONNECTED TO THE DEVICE. THE COMPLAINT DEVICE WAS BLOCKED WITH CRYSTALIZED SALINE SOLUTION; SO THE DEVICE WAS SOAKED IN WARM WATER TO DISSOLVE THE BLOCKAGE. THE COMPLAINT DEVICE WAS THEN FUNCTIONALLY TESTED AND IT WAS NOTED THAT NO PRESSURE WAS ABLE TO BE PRODUCED. THE DEVICE WAS DISMANTLED AND IT WAS FOUND THAT THE BLACK O-RING BEHIND THE GAUGE WAS MISSING. THE DEVICE COULD NOT BE INFLATED DUE TO THE O-RING MISSING, THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. HOWEVER, IT IS POSSIBLE THAT THE COMPLAINT DEVICE WAS ABLE TO INFLATE DURING THE PROCEDURE BUT COULD NOT BE DEFLATED DUE TO THE O-RING MISSING. IT IS LIKELY THAT THE O-RING WAS NOT INSERTED DURING THE MANUFACTURE PROCEDURE; THEREFORE THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING. FURTHER ANALYSIS AND INVESTIGATION ARE BEING CONDUCTED TO CORRECT THE ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE PATIENT IS OVER 18 YEARS. (B)(4) FOR THE REPORTED EVENT OF DEFLATION ISSUES. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2012-06144 ADDRESSES THE MAXFORCE BALLOON, WHILE MANUFACTURER REPORT # 3005099803-2012-06297 ADDRESSES THE ENCORE INFLATION DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT A MAXFORCE BILIARY CATHETER BALLOON AND AN ENCORE INFLATION DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT (CBD) ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, WHEN THE PROCEDURE WAS COMPLETED, THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON; HOWEVER THE INFLATION MEDIUM WAS UNABLE TO BE REMOVED WITH THE ENCORE DEVICE. ANOTHER SYRINGE WAS ATTACHED TO THE BALLOON TO REMOVE THE INFLATION MEDIUM; HOWEVER THIS WAS UNSUCCESSFUL. THE DEVICE WAS REMOVED WITH THE SCOPE; AND ONCE OUTSIDE THE PATIENT THE DEVICE WAS ABLE TO BE REMOVED FROM THE SCOPE. THE PROCEDURE WAS COMPLETED WITH THIS MAXFORCE BALLOON AT THIS POINT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2012-06144 ADDRESSES THE MAXFORCE BALLOON, WHILE MANUFACTURER REPORT # 3005099803-2012-06297 ADDRESSES THE ENCORE INFLATION DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT A MAXFORCE BILIARY CATHETER BALLOON AND AN ENCORE INFLATION DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT (CBD) ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, WHEN THE PROCEDURE WAS COMPLETED, THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON; HOWEVER THE INFLATION MEDIUM WAS UNABLE TO BE REMOVED WITH THE ENCORE DEVICE. ANOTHER SYRINGE WAS ATTACHED TO THE BALLOON TO REMOVE THE INFLATION MEDIUM; HOWEVER THIS WAS UNSUCCESSFUL. THE DEVICE WAS REMOVED WITH THE SCOPE; AND ONCE OUTSIDE THE PATIENT THE DEVICE WAS ABLE TO BE REMOVED FROM THE SCOPE. THE PROCEDURE WAS COMPLETED WITH THIS MAXFORCE BALLOON AT THIS POINT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE 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 SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK M00566670 14849235

    Patients

    Seq Age Sex Outcome Treatment
    1