BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE CELLFINA SYSTEM

    MDR report key: 8992322 · Received September 11, 2019

    Report

    Report Number
    3006560326-2019-00020
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 14, 2019
    Report Date
    August 15, 2019
    Manufacturer
    ULTHERA, INC. MERZ DEVICE INNOVATION CENTER
    Product Code
    OUP
    PMA / PMN Number
    K192185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE CELLFINA PREP PACK ASSOCIATED WITH THIS EVENT WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION. DURING EVALUATION, A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED PRODUCT. THE STERILE SUCTION TUBING SHOWED NO SIGNS OF WEAR OR DAMAGE. THE TUBE CONNECTOR COMPONENT OF THE CELLFINA SYSTEM USED TO CONNECT THE TUBING WITH THE VACUUM PUMP WAS NOT INCLUDED WITH THE RETURNED KIT; THEREFORE, THE TUBING COULD NOT BE CONNECTED TO A SUCTION PUMP TO INVESTIGATE THE ISSUE. THE PRACTICE ALLEGED THE CONNECTOR COMPONENT WAS CRACKED; HOWEVER, AS THE COMPONENT WAS NOT RETURNED FOR EVALUATION THIS ISSUE COULD NOT BE CONFIRMED. BASED ON THE FINDINGS OF THIS INVESTIGATION, THE REPORTED ISSUES OF CP1 COMPONENT ISSUE AND VACUUM LOSS OF PRESSURE COULD NOT BE CONFIRMED DUE TO THE MISSING COMPONENT. AN EVALUATION OF THE LOT HISTORY RECORD FOR THIS CELLFINA PREP PACK REVEALED NO NON-CONFORMANCES, DEVIATIONS, OR REWORK ASSOCIATED WITH THE MANUFACTURE OF THIS LOT ((B)(4)WERE MANUFACTURED FOR THIS LOT). ALL REQUIRED TESTING WAS PASSED PRIOR TO DISTRIBUTION. A REVIEW OF THE LOT COMPLAINT HISTORY REVEALED NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT OF CELLFINA PREP PACKS. A REVIEW OF THE CELLFINA PRODUCT COMPLAINT TRENDING ANALYSIS FOUND THAT THE REPORTED ISSUES OF VACUUM LOSS OF PRESSURE AND CP1 COMPONENT ISSUE DID NOT OCCUR AT A HIGH ENOUGH FREQUENCY TO GENERATE A TREND AND WILL CONTINUE TO BE MONITORED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH FORM WILL BE SUBMITTED.

    Description of Event or Problem · 0

    A PRACTICE REPORTED TO A SALES REPRESENTATIVE ON 2019 THAT DURING CELLFINA TREATMENT ON A PATIENT, A SUCTION HOSE CONNECTOR SPONTANEOUSLY DETACHED ITSELF FROM THE TEMPLATE AND THE HOSE FELL TO THE GROUND. NO PATIENT IMPACT RESULTED FROM THIS ISSUE, AND A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SALES REPRESENTATIVE STATING THE TUBING CONNECTOR COMPONENT OF THE PREP PACK CRACKED. NO FURTHER DETAILS INTO HOW THE CONNECTOR COMPONENT CRACKED WERE OBTAINED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS REPORTED TO BE AVAILABLE FOR INVESTIGATION; HOWEVER, IT HAS NOT BEEN RECEIVED AS OF THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A PRACTICE REPORTED TO A SALES REPRESENTATIVE ON (B)(6) 2019 THAT DURING CELLFINA TREATMENT ON A PATIENT, A SUCTION HOSE CONNECTOR SPONTANEOUSLY DETACHED ITSELF FROM THE TEMPLATE AND THE HOSE FELL TO THE GROUND. NO PATIENT IMPACT RESULTED FROM THIS ISSUE, AND A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784559 THE CELLFINA SYSTEM CELLFINA SYSTEM OUP ULTHERA, INC. MERZ DEVICE INNOVATION CENTER CP1 - EU 100118445

    Patients

    Seq Age Sex Outcome Treatment
    1