BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION QUATTRO EXTRACTION BALLOON

    MDR report key: 14455728 · Received May 20, 2022

    Report

    Report Number
    1037905-2022-00227
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 21, 2022
    Report Date
    May 19, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    GCA
    UDI-DI
    10827002319216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON NAME AND PRODUCT CODE: GCA BILIARY CATHETER FOR STONE REMOVAL THAT MAY ALSO ALLOW FOR IRRIGATION AND CONTRAST INJECTION. 510K: K063677. INVESTIGATION EVALUATION: THE DEVICE WAS RETURNED IN AN UNMARKED CLEAR POUCH WITH NO LOT NUMBER FOR THE DEVICE. PER THE PHOTO PROVIDED, THE LOT NUMBER/RPN IS NOT SHOWN. THE PHOTO SHOWS THE BALLOON DEFLATED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT AS IT WAS DESCRIBED, BECAUSE THE PREPACKAGED SYRINGE WAS NOT INCLUDED IN THE RETURN. A FUNCTIONAL TEST WAS PERFORMED ON THE BALLOON USING A LAB STOCK SYRINGE. THE SYRINGE WAS ATTACHED TO THE INFLATION PORT. WHEN THE BALLOON WAS FILLED WITH AIR, NO LEAKS WERE PRESENT IN THE BALLOON MATERIAL. ONCE THE BALLOON WAS INFLATED, PRESSURE WAS RELEASED FROM THE SYRINGE AND THE BALLOON DEFLATED WITHIN A FEW SECONDS. THE DEVICE WAS VISUALLY INSPECTED AND APPEARED TO BE FREE OF BENDS AND KINKS ALONG THE CATHETER OF THE DEVICE. THE DEVICE WAS MEASURED FROM THE HUB TO THE DISTAL END AND MEASURED WITHIN THE SPECIFIED TOLERANCE. THE COMPLAINT IS CONSIDERED CONFIRMED BASED SOLELY ON THE STATEMENTS DESCRIBING THE EVENT. 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 CONCLUSION: THE EVALUATION CONFIRMED THE REPORT BASED ON THE CUSTOMERS STATEMENTS DESCRIBING THE EVENT; BUT THE REPORT COULD NOT BE CONFIRMED AS DESCRIBED BECAUSE THE BALLOON INFLATED AND DEFLATED WITH AIR WITHIN A FEW SECONDS WITH THE LAB STOCK SYRINGE. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE PRODUCT SAID TO BE INVOLVED FUNCTIONED AS INTENDED WITH THE PROVIDED LAB STOCK SYRINGE; HOWEVER A FULL EVALUATION WAS NOT ABLE TO BE COMPLETED DUE TO THE SYRINGE NOT BEING RETURNED WITH THE BALLOON. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. 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 MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN ISOLATED OCCURRENCE. 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 · 0

    IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK FUSION QUATTRO EXTRACTION BALLOON. IT WAS REPORTED [THAT] THE [EXTRACTION] BALLOON CANNOT BE DEFLATED WHILE THE PHYSICIAN TESTED THE DEVICE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186145 FUSION QUATTRO EXTRACTION BALLOON GCA WILSON-COOK MEDICAL INC W4514035 10827002319216

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown