BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSION QUATTRO EXTRACTION BALLOON

    MDR report key: 2181083 · Received July 22, 2011

    Report

    Report Number
    1037905-2011-00493
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    GCA
    PMA / PMN Number
    K063677
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT WAS PROVIDED TO US BY THE COOK FACILITY IN (B)(4) ON BEHALF OF A MEDICAL FACILITY IN (B)(6). (B)(6). (B)(4). ADD'L COMMENTS REGARDING THIS REPORT: THE COOK AREA REP FOR (B)(6) WAS FIRST MADE AWARE OF THIS OCCURRENCE ON (B)(6) 2011. THE NATURE OF THE COMPLAINT WAS NOT PROVIDED TO THE DESIGNATED COMPLAINT HANDLING UNIT AT THAT TIME. ON (B)(6) 2011, PHOTOGRAPHS TAKEN DURING THE PROCEDURE WERE PROVIDED. THE EXACT NATURE OF THE COMPLAINT (AS LISTED IN THE DESCRIPTION OF THE EVENT) WAS PROVIDED VIA EMAIL ON (B)(6) 2011. THIS HAS BEEN COMMUNICATED TO THE APPROPRIATE PERSONNEL TO ENSURE TIMELY COMPLAINT REPORTING OCCURS IN THE FUTURE. EVAL: A PRODUCT EVAL WAS NOT PERFORMED SINCE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVAL. PHOTOS TAKEN DURING THE PROCEDURE WERE PROVIDED FOR OUR REVIEW. BY VIEWING THE PHOTOGRAPHS, WE CONFIRMED THE BALLOON COMPONENT HAS SEPARATED FROM THE CATHETER AND APPEARS TO HAVE MAINTAINED ITS CYLINDRICAL SHAPE. THE EXACT NATURE OF THE DETACHMENT AND THE CAUSE IS DIFFICULT TO DETERMINE FROM VIEWING THE PHOTOGRAPHS. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN INVENTORY. CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. PRIOR TO DISTRIBUTION, ALL FUSION QUATTRO EXTRACTION BALLOONS ARE SUBJECTED TO A VISUAL AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. THE FUNCTIONAL TEST INCLUDES AN AIR INFLATION TEST TO ENSURE PROPER BALLOON FUNCTION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THERE HAVE BEEN NO OTHER SIMILAR OCCURRENCES DURING THE TIME PERIOD REVIEWED. THEREFORE, THIS REPORT REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. A PIECE OF THE BALLOON DETACHED FROM THE CATHETER DURING USE. THE PIECE OF DETACHED BALLOON WAS RETRIEVED ENDOSCOPICALLY WITH BIOPSY FORCEPS. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION QUATTRO EXTRACTION BALLOON GCA, CATHETER, BILIARY, SURGICAL GCA WILSON-COOK MEDICAL, INC. W2965698

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DILATION SYRINGE (UNK TYPE)