BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCEPTER C OCCLUSION BALLOON

    MDR report key: 13416785 · Received February 1, 2022

    Report

    Report Number
    2032493-2022-00042
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    January 6, 2022
    Report Date
    January 6, 2022
    Manufacturer
    MICROVENTION, INC.
    Product Code
    MJN
    UDI-DI
    04987350879875
    PMA / PMN Number
    K113698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY DEVICE EVALUATION: INVESTIGATION FOUND A PUSHED FORWARD COIL, DISTAL DELAMINATION, AND A TEAR IN THE BALLOON, CONSISTENT WITH THE ALLEGED PRODUCT ISSUE. THE PHYSICAL EVALUATION OF THE DEVICE COULD NOT IDENTIFY THE CONDITIONS OR CIRCUMSTANCES THAT LED TO THE DAMAGE, BUT THE DAMAGE IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES OVER SPECIFICATION.

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE INVESTIGATION IS CURRENTLY ONGOING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SCEPTER C OCCLUSION BALLOON RUPTURED DURING TREATMENT OF A SAH WHEN A COMPETITOR'S IMPLANT COIL WAS IN THE PROCESS OF BEING DETACHED. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SCEPTER C OCCLUSION BALLOON RUPTURED DURING TREATMENT OF A SAH WHEN A COMPETITOR'S IMPLANT COIL WAS IN THE PROCESS OF BEING DETACHED. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212507 SCEPTER C OCCLUSION BALLOON BALLOON CATHETER MJN MICROVENTION, INC. MV-BCA41015 21062352Y 04987350879875

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown