BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONETOME¿

    MDR report key: 2493545 · Received March 15, 2012

    Report

    Report Number
    3005099803-2012-00997
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Date of Event
    January 19, 2012
    Report Date
    March 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQR
    PMA / PMN Number
    K946358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO LOT NUMBERS (14369141 OR 14882778) WERE PROVIDED FOR THE RELATED COMPLAINT DEVICES, THE COMPLAINANT COULD NOT IDENTIFY WHICH LOT NUMBER BELONGED TO THE TWO COMPLAINT DEVICES. THE REPORTED LOT NUMBER COULD NOT BE MATCHED TO THE REPORTED DEVICE. THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN AT THIS TIME. (B)(4) FOR THE INVESTIGATION RESULTS OF BALLOON TORN/DAMAGED. (B)(4) FOR THE INVESTIGATION RESULTS OF CATHETER AND CUT WIRE BENT. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE WORKING LENGTH WAS TWISTED AND SLIGHTLY BENT. THE CUT WIRE WITHIN THE EXTRUSION WAS SLIGHTLY BENT NEAR THE HANDLE ASSEMBLY. THE EXPOSED CUTWIRE WAS FOUND DISCOLORED/BLACKENED. FUNCTIONALLY, THE BALLOON WAS UNABLE TO INFLATE DUE TO DAMAGE (TORN/RUPTURED). DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED SO THE CONDITION OF THE DEVICE IS LIKELY DUE TO PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2012-00920 AND MFR. REPORT # 3005099803-2012-00997). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO STONETOME SPHINCTEROTOMES WERE USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ONE OF THE TWO STONETOME DEVICES WAS UNABLE TO BOW AND THE OTHER STONETOME'S BALLOON WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME SPHINCTEROTOME. 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 STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; BALLOON TORN/DAMAGED; WORKING LENGTH AND CUT WIRE BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONETOME¿ DISLODGER, STONE, BILIARY LQR BOSTON SCIENTIFIC - SPENCER M00535110

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR