BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTRACTOR¿ PRO DL

    MDR report key: 2780878 · Received October 10, 2012

    Report

    Report Number
    3005099803-2012-04597
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 18, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    FGE
    PMA / PMN Number
    K102082
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. THE REPORTED EVENT THAT THE CATHETER DISTAL TIP DETACHED. 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.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS RECEIVED, THEREFORE THE MANUFACTURE AND EXPIRATION DATES ARE NOW KNOWN. INVESTIGATION RESULTS: EVALUATION OF COMPLAINT DEVICE WAS PERFORMED. VISUAL INSPECTION DID NOT CONFIRM THAT THE DISTAL TIP OF THE BALLOON DETACHED, HOWEVER, IT WAS FOUND THAT THE CATHETER BROKE IN HALF. THE CATHETER WAS FOUND TO BE STRETCHED AT THE POINT OF BREAKAGE. THIS IS CONSISTENT WITH EXCESSIVE REMOVAL FORCE DURING WITHDRAWAL THROUGH THE SCOPE. THE ROOT CAUSE FOR THE REPORTED EVENT IS OPERATIONAL CONTEXT. THIS FAILURE OCCURS DUE TO ANATOMICAL OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE THAT LIMIT THE PERFORMANCE OF THE DEVICE (E.G. TORTUOUS ANATOMY OR CATHETER CAUGHT ON SCOPE ELEVATOR). 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. A REVIEW OF THE DEVICE LABELING AND DIRECTIONS FOR USE SHOWED THE DEVICE WAS USED ACCORDING TO ITS LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED ON (B)(6) 2012 DURING A BILIARY STONE EXTRACTION PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE CATHETER BROKE JUST AFTER THE BALLOON. NO PARTICULAR RESISTANCE WAS REPORTED DURING THE PROCEDURE. THE DETACHED FRAGMENT WAS REMOVED USING FORCEPS. THE PROCEDURE WAS COMPLETED USING ANOTHER EXTRACTOR BALLOON. THERE WERE NO OTHER PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED ON (B)(6) 2012 DURING A BILIARY STONE EXTRACTION PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE CATHETER BROKE JUST AFTER THE BALLOON. NO PARTICULAR RESISTANCE WAS REPORTED DURING THE PROCEDURE. THE DETACHED FRAGMENT WAS REMOVED USING FORCEPS. THE PROCEDURE WAS COMPLETED USING ANOTHER EXTRACTOR BALLOON. THERE WERE NO OTHER PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR¿ PRO DL CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - CORK M00547200 15063300

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention