BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMTOME¿ RX 44

    MDR report key: 2213228 · Received August 16, 2011

    Report

    Report Number
    3005099803-2011-02764
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. 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 OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH WAS TWISTED, THE EXPOSED CUT WIRE WAS BROKEN AND THE BROKEN ENDS OF THE CUTTING WIRE APPEARED DISCOLORED AND BLACKENED. THE OUTER DIAMETER (OD) OF THE EXPOSED CUT WIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. ADDITIONALLY, THE CLOSED EXTRUSION AT THE DISTAL TIP WAS RIPPED. THE RIP EXISTED FROM THE POINT WHERE THE GUIDE WIRE CHANNEL ENDS, TO THE TIP, TEARING OPEN THE CLOSED EXTRUSION THROUGH THE DISTAL TIP AND SPLITTING THE TIP. DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED, THE BROKEN CUT WIRE IS LIKELY DUE TO PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. REPORT # 3005099803-2011-02763 AND MFR. REPORT # 3005099803-2011-02764). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO DREAMTOME RX SPHINCTEROTOMES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE INDICATION OF THE PROCEDURE WAS TREATMENT FOR BILE DUCT STONES. DURING THE PROCEDURE, THE SPHINCTEROTOME (THE SUBJECT OF MFR. REPORTER # 3005099803-2011-02763) WAS INTRODUCED INTO THE PATIENT AND POSITIONED IN THE COMMON BILE DUCT. HOWEVER, WHEN THE CUTTING WIRE WAS ENERGIZED TO PERFORM THE SPHINCTEROTOMY, THE CUTTING WIRE BROKE. THE CUTTING WIRE REMAINED CONNECTED TO THE DEVICE AND NO PORTION OF THE WIRE DETACHED INSIDE OF THE PATIENT. A SECOND DREAMTOME RX SPHINCTEROTOME (THE SUBJECT OF MFR. REPORTER # 3005099803-2011-02764) WAS INTRODUCED INTO THE PATIENT AND POSITIONED WITHIN THE COMMON BILE DUCT. HOWEVER, AGAIN, WHEN THE CUTTING WIRE WAS ENERGIZED TO PERFORM THE SPHINCTEROTOMY, THE CUTTING WIRE BROKE. THE CUTTING WIRE REMAINED CONNECTED TO THE DEVICE AND NO PORTION OF THE WIRE DETACHED INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A THIRD DREAMTOME RX SPHINCTEROTOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. REPORT # 3005099803-2011-02763 AND MFR. REPORT # 3005099803-2011-02764). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO DREAMTOME RX SPHINCTEROTOMES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE INDICATION OF THE PROCEDURE WAS TREATMENT FOR BILE DUCT STONES. DURING THE PROCEDURE, THE SPHINCTEROTOME (THE SUBJECT OF MFR. REPORTER # 3005099803-2011-02763) WAS INTRODUCED INTO THE PATIENT AND POSITIONED IN THE COMMON BILE DUCT. HOWEVER, WHEN THE CUTTING WIRE WAS ENERGIZED TO PERFORM THE SPHINCTEROTOMY, THE CUTTING WIRE BROKE. THE CUTTING WIRE REMAINED CONNECTED TO THE DEVICE AND NO PORTION OF THE WIRE DETACHED INSIDE OF THE PATIENT. A SECOND DREAMTOME RX SPHINCTEROTOME (THE SUBJECT OF MFR. REPORTER # 3005099803-2011-02764) WAS INTRODUCED INTO THE PATIENT AND POSITIONED WITHIN THE COMMON BILE DUCT. HOWEVER, AGAIN, WHEN THE CUTTING WIRE WAS ENERGIZED TO PERFORM THE SPHINCTEROTOMY, THE CUTTING WIRE BROKE. THE CUTTING WIRE REMAINED CONNECTED TO THE DEVICE AND NO PORTION OF THE WIRE DETACHED INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A THIRD DREAMTOME RX SPHINCTEROTOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DREAMTOME¿ RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00584060 0013884663

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR