BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUDI CURETTE, 0, 5IN

    MDR report key: 19863790 · Received July 30, 2024

    Report

    Report Number
    3005172759-2024-00080
    Event Type
    Injury
    Date Received
    July 30, 2024
    Date of Event
    July 11, 2024
    Report Date
    August 28, 2024
    Manufacturer
    ACCLARENT, INC.
    Product Code
    PGW
    PMA / PMN Number
    K201174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). UPDATED SECTIONS ON THIS MED WATCH: B4, G3, G6, H2, H3, H6 AND H11. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO NON-CONFORMANCES RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. SECTION H3 - THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. BASED ON THE INFORMATION CONTAINED IN THE COMPLAINT AT THE TIME THE REPORTING DETERMINATION WAS MADE, THIS COMPLAINT IS DEEMED REPORTABLE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ACCLARENT, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ACCLARENT, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT ENT (EAR, NOSE & THROAT) PROCEDURE WITH ACCLARENT DEVICES, EXPERIENCED LEAKING OF CEREBROSPINAL FLUID (CSF). THE CALLER REPORTED THAT DURING THE PROCEDURE, IT WAS NOTICED THAT THE PATIENT'S NASAL CAVITY WAS LEAKING CEREBROSPINAL FLUID (CSF). THE CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED TO THE PATIENT WAS A GRAFT OFF THE EAR, IN ORDER TO PACK THE CSF LEAK. IT WAS NOTED THAT THE PATIENT IS IN STABLE CONDITION. IT WAS ALSO REPORTED THAT THE RELIEVA SPINPLUS BALLOON WIRE BECAME KINKED DURING THE PROCEDURE, TOWARDS THE DISTAL END. THE RELIEVA SPINPLUS BALLOON WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. THE CALLER ALSO REPORTED THAT LATER IN THE PROCEDURE, THE TRUDI NAVIGATION SYSTEM ACCURACY WAS OFF BY ABOUT 5MM, FOR ALL NAVIGATED DEVICES. THE PATIENT WAS RE-REGISTERED WITHOUT RESOLUTION. THE CALLER TRIED TO TEST TWO DIFFERENT TRUDI NAV SUCTION DEVICES, BUT THE ISSUE STILL PERSISTED. THE CALLER ALSO OPEN A NEW TRUDI CURETTE, WITHOUT RESOLUTION. THE PROCEDURE CONTINUED WITH THE ACCURACY ISSUE PERSISTING. ADDITIONAL INFORMATION RECEIVED ON 25-JUL-2024. IT WAS NOTED THAT THE PATIENT HAD INTERSINUS CALCIFICATION AS A PREEXISTING CONDITION, THE CUSTOMER CONFIRMED ACCURACY USING THE REGISTRATION PROBE AFTER REGISTRATION PROCESS WAS COMPLETED. ACCURACY WAS DETERMINED BY TOUCHING KEY LANDMARKS WITH THE SUCTION IE SEPTUM, MIDDLE TURBINATE, MAXILLARY SINUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240997 TRUDI CURETTE, 0, 5IN EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT PGW ACCLARENT, INC. 221215B-PC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R