BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION QUATTRO EXTRACTION BALLOON

    MDR report key: 19492711 · Received June 7, 2024

    Report

    Report Number
    1037905-2024-00313
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    April 12, 2024
    Report Date
    June 7, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    GCA
    UDI-DI
    10827002319216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510(K): K200247. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE DEVICE WAS RETURNED WITHOUT THE SYRINGE. THE BALLOON WAS RUPTURED AND EXAMINED UNDER MAGNIFICATION. UNDER MAGNIFICATION, IT WAS IDENTIFIED THERE WAS A PORTION WHERE THE BALLOON MATERIAL DID NOT MATCH UP AND A PORTION APPEARS TO BE MISSING. THE MISSING PORTION OF THE BALLOON WAS NOT RETURNED WITH THE DEVICE. 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: OUR EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT, THE BALLOON MATERIAL RUPTURED. A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. IN THE INFORMATION PROVIDED IN THE REPORT, IT STATES THE BALLOON WAS TESTED PRIOR TO ADVANCEMENT DOWN THE ENDOSCOPE ACCESSORY CHANNEL AND INFLATED PROPERLY. A PINHOLE, SPLIT, OR RUPTURE IN THE BALLOON CAN OCCUR IF THE BALLOON MATERIAL HAS COME INTO CONTACT WITH A SHARP OBJECT, SUCH AS A SHARP STONE OR POSSIBLY A BURR IN THE ENDOSCOPE CHANNEL. A SPLIT OR RUPTURE IN THE BALLOON MATERIAL CAN ALSO OCCUR IF ADDED PRESSURE WAS APPLIED DURING EXTRACTION. THE INSTRUCTIONS FOR USE DIRECT THE USER TO "GENTLY WITHDRAW THE INFLATED BALLOON TOWARD THE PAPILLA". THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING: "WARNING: DO NOT EXERT EXCESSIVE PRESSURE ON AMPULLA WHILE EXTRACTING STONES. IF STONE DOES NOT PASS EASILY, REASSESS NEED FOR SPHINCTEROTOMY". PRIOR TO DISTRIBUTION, ALL FUSION QUATTRO EXTRACTION BALLOON 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 · 0

    DURING THE ENDOSCOPIC STONE EXTRACTION IN THE BILIARY DUCT, THE PHYSICIAN USED TWO FUSION QUATTRO EXTRACTION BALLOONS. IT WAS INITIALLY REPORTED THAT SEVERAL BALLOONS WERE PUNCTURED, WITHOUT PARTICULAR CONSTRAINT IMPOSED ON THEM. ATTEMPTS WERE MADE WITH TWO BATCHES DIFFERENT WITH THE SAME RESULT. THIS RECURRING PHENOMENON HAS OCCURRED ON SEVERAL PATIENTS THIS WEEK. FOR THIS EXAMPLE, THE DEVICES WERE REPLACED EACH TIME WITH FOUR BALLOONS ON A SINGLE PATIENT. THIS HAS NOT HISTORICALLY LED TO A SERIOUS INJURY TO THE PATIENT SO IT WAS NOT CONSIDERED REPORTABLE. ONE OF THE DEVICES WAS RETURNED ON 15 MAY 2024 AND A PIECE APPEARED TO BE MISSING FROM THE DEVICE. THIS MAKES THE EVENT REPORTABLE. A SECTION OF THE DEVICE DID NOT 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
    1311571 FUSION QUATTRO EXTRACTION BALLOON GCA, CATHETER, BILIARY, SURGICAL GCA WILSON-COOK MEDICAL INC W4729725 10827002319216

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DUODENOSCOPE OLYMPUS 190| WIRE GUIDE JAGWIRE 0.035 - 260CM