BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BALLOON CATHETER 1ST GEN

    MDR report key: 10532322 · Received September 14, 2020

    Report

    Report Number
    3005172759-2020-00005
    Event Type
    Injury
    Date Received
    September 14, 2020
    Date of Event
    August 1, 2017
    Report Date
    August 21, 2020
    Manufacturer
    ACCLARENT, INC.
    Product Code
    PNZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO: (B)(4). NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING COMPLICATIONS WERE REPORTED IN THIS PUBLICATION: IT WAS REPORTED FROM KOREA THAT A (B)(6) MALE PATIENT UNDERWENT BILATERAL BALLOON EUSTACHIAN TUBOPLASTY (BET) USING AN ACCLARENT BALLOON CATHETER (UNKNOWN PRODUCT CODE). THE BALLOON CATHETER WAS PASSED 2 CM INTO BOTH EUSTACHIAN TUBES (ETS) UNDER A 30° ENDOSCOPIC VISION. THE BALLOON WAS INFLATED TO A PRESSURE OF 12 BAR FOR 2 MINUTES AND FURTHER FOR 1 MINUTE. THE OPERATOR FACED NO NOTABLE DIFFICULTY DURING THE PROCEDURE, EXCEPT FOR SOME RESISTANCE WHEN PROCEEDING WITH THE BALLOON TIP IN THE LEFT ET. SIXTEEN MONTHS AFTER THE SECOND PROCEDURE, THE VALSALVA MANEUVER COULD BE SUCCESSFULLY PERFORMED FOR THE RIGHT BUT NOT FOR THE LEFT EAR. NASOPHARYNGOSCOPY REVEALED A NEWLY FORMED BULGING LESION AT THE LEFT ROSENMULLER FOSSA. COMPUTED TOMOGRAPHY AND MAGNETIC RESONANCE IMAGING SHOWED A MUCOCELE LIKE ENCAPSULATED LESION, MEASURING APPROXIMATELY 2 CM, AT THE ROSENMULLER FOSSA, WHICH WAS NOT OBSERVED ON THE PREOPERATIVE COMPUTED TOMOGRAPHIC FINDINGS. SURGICAL INTERVENTION WAS MARSUPIALIZATION ( SURGICAL TECHNIQUE OF CUTTING A SLIT INTO AN ABSCESS OR CYST AND SUTURING THE EDGES OF THE SLIT TO FORM A CONTINUOUS SURFACE FROM THE EXTERIOR SURFACE TO THE INTERIOR SURFACE OF THE CYST OR ABSCESS) OF THE NASOPHARYNGEAL MUCOCELE USING A MICRODEBRIDER AND LEFT BET WERE PERFORMED UNDER GENERAL ANESTHESIA AT 1-YEAR FOLLOW-UP THE PATIENT REMAINED WITHOUT RECURRENCE OF THE MUCOCELE. THERE ARE 0 DEATH EVENTS AND 0 DEVICE MALFUNCTIONS REPORTED IN THIS PUBLICATION. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS UNKNOWN BALLOON CATHETER. PUBLICATION DETAILS TITLE: NASOPHARYNGEAL MUCOCELE FOLLOWING BALLOON EUSTACHIAN TUBOPLASTY. OBJECTIVE: 3 TO OUR KNOWLEDGE, NO DEVICE- OR PROCEDURE-RELATED COMPLICATIONS OF BET HAVE BEEN REPORTED TO DATE. HERE, WE REPORT A CASE OF NASOPHARYNGEAL MUCOCELE FOLLOWING BET THAT REQUIRED SURGICAL TREATMENT. METHODS: REVIEW OF CASE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991713 UNKNOWN BALLOON CATHETER 1ST GEN UNKNOWN PNZ ACCLARENT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention