BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR PRO RX

    MDR report key: 2160855 · Received July 13, 2011

    Report

    Report Number
    3005099803-2011-02246
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    May 20, 2011
    Report Date
    June 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    FGE
    PMA / PMN Number
    K102082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE AND WEIGHT ARE UNKNOWN. IT WAS REPORTED THE PATIENT WAS OVER 18 YEARS OLD. VISUAL EVALUATION OF THE RETURNED COMPLAINT DEVICE CONFIRMED THE BALLOON TO BE BURST; THE BALLOON WAS FOUND TO BE DETACHED FROM THE CATHETER. INSPECTION OF THE CATHETER OF THE DEVICE REVEALED A KINK BELOW THE BALLOON AND DAMAGE TO THE C-CHANNEL. THE DAMAGED C-CHANNEL CREATED A JAGGED EDGE IN THE CATHETER. THE DAMAGE NOTED TO THE CATHETER OF THE DEVICE MAY BE DUE TO EXCESSIVE FORCE USED IN REMOVING THE GUIDEWIRE FROM THE C-CHANNEL. BALLOON BURST MOST LIKELY OCCURRED DUE TO CONTACT WITH A SHARP EXTERIOR SOURCE (SUCH AS A STONE). BASED ON THIS INFORMATION, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT; THIS FAILURE OCCURS WHEN PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE LIMIT THE PERFORMANCE OF THE DEVICE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED DURING A STONE REMOVAL PROCEDURE PERFORMED ON A FEMALE PATIENT ON (B)(6), 2011 (PATIENT AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST WHILE REMOVING STONES AND SLUDGE FROM THE BILE DUCT. NO DAMAGE WAS NOTED TO THE DEVICE UPON UNPACKING OR THE PACKAGING OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE (UNKNOWN MODEL/UPN). 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. INVESTIGATION RESULTS REVEALED THE C-CHANNEL OF THE CATHETER TO BE DAMAGED, WHICH WAS NOT INITIALLY REPORTED BY THE COMPLAINANT; THEREFORE THIS IS NOW AN MDR REPORTABLE EVENT .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR PRO RX CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - CORK M00547020 13952222

    Patients

    Seq Age Sex Outcome Treatment
    1