BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION QUATTRO EXTRACTION BALLOON

    MDR report key: 20893165 · Received December 10, 2024

    Report

    Report Number
    1037905-2024-00792
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    September 24, 2024
    Report Date
    January 6, 2025
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    GCA
    UDI-DI
    10827002482255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K):K200247. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    PMA/510(K): K200247. 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. A PHOTO OF THE DEVICE LABEL WAS PROVIDED. THE LOT NUMBER AND RPN ON THE LABEL MATCHES THE ONE IN THE REPORT. 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: 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. 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: 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 REPORTED OCCURRENCES SIMILAR IN NATURE DURING THE TIME PERIOD REVIEWED. THEREFORE, THIS REPORT IS AN ISOLATED OCCURRENCE. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 0

    DURING A STONE EXTRACTION PROCEDURE, THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. IT WAS REPORTED THAT THE BALLOON TIP IS VERY STIFF AND TRAUMATIC WHICH MAY CAUSE INJURY TO THE PATIENT. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. NEW INFORMATION WAS RECEIVED ON 03OCT2024 STATING THAT WHILE PULLING THE BALLOON OUT TO EXTRACT THE STONE, THE WIRE [GUIDE] COMES OUT WITH THE BALLOON, WHICH REQUIRES RE-CANNULATION [LOST WIRE GUIDE ACCESS, SUBJECT OF REPORT]. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2521738 FUSION QUATTRO EXTRACTION BALLOON GCA, CATHETER, BILIARY, SURGICAL GCA WILSON-COOK MEDICAL INC G48225 W4838638 10827002482255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN ENDOSCOPE