BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 1881646 · Received October 25, 2010

    Report

    Report Number
    3005099803-2010-04492
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    FGE
    PMA / PMN Number
    K041606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. 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 REVEALED NO ISSUES. THE PROXIMAL AND DISTAL BONDS WERE EXAMINED AND FOUND TO BE MEETING SPECIFICATION, THERE WAS NO DAMAGE NOTED TO THE DEVICE AND THE BALLOON WAS ABLE TO BE INFLATED SUCCESSFULLY. ONCE, INFLATED THE STOPCOCK WAS THEN OPENED AND THE BALLOON DEFLATED SPONTANEOUSLY BY ITSELF; NO ISSUES WERE NOTED. THE REPORTED DEFECT WAS NOT CONFIRMED. THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE OPERATIONAL CONTEXT, AS SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED DEFLATION DIFFICULTIES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR RX BALLOON WAS USED IN A STONE REMOVAL PROCEDURE ON (B)(6) 2010. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE THE BALLOON WAS UNABLE TO DEFLATE WHEN NEGATIVE PRESSURE WAS PROVIDED BY THE SYRINGE. THE SYRINGE WAS RECONNECTED TO THE DEVICE SEVERAL TIMES, AND EVENTUALLY WAS ABLE TO DEFLATE THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION HAD BEEN DESCRIBED AS "GOOD."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR RX BALLOON WAS USED IN A STONE REMOVAL PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE THE BALLOON WAS UNABLE TO DEFLATE WHEN NEGATIVE PRESSURE WAS PROVIDED BY THE SYRINGE. THE SYRINGE WAS RECONNECTED TO THE DEVICE SEVERAL TIMES, AND EVENTUALLY WAS ABLE TO DEFLATE THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION HAD BEEN DESCRIBED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - CORK M00546940 13435573

    Patients

    Seq Age Sex Outcome Treatment
    1