BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION QUATTRO EXTRACTION BALLOON

    MDR report key: 4945725 · Received July 23, 2015

    Report

    Report Number
    1037905-2015-00306
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Date of Event
    June 26, 2015
    Report Date
    June 29, 2015
    Manufacturer
    WISLON-COOK MEDICAL INC.
    Product Code
    GCA
    PMA / PMN Number
    K063677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. 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. INVESTIGATION CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE STATE, "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS OR BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE." PRIOR TO DISTRIBUTION, ALL FUSION QUATTRO EXTRACTION BALLOONS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. THE CUSTOMER CLAIMED THAT THE LITTLE BLACK RINGS (RADIOPAQUE BANDS) AT THE TIP (NEAR THE BALLOON) BROKE OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. OTHER THAN THE RADIOPAQUE BANDS LEFT TO PASS NATURALLY, A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478135 FUSION QUATTRO EXTRACTION BALLOON CATHETER, BILIARY, SURGICAL GCA WISLON-COOK MEDICAL INC. W3575399

    Patients

    Seq Age Sex Outcome Treatment
    1