BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCEPTER XC

    MDR report key: 18278379 · Received December 6, 2023

    Report

    Report Number
    2032493-2023-01095
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    November 21, 2023
    Report Date
    July 22, 2024
    Manufacturer
    MICROVENTION, INC.
    Product Code
    DQY
    PMA / PMN Number
    K121785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. THE FOLLOWING FIELDS HAVE BEEN CORRECTED: D2A - COMMON DEVICE NAME. THE DEVICE CONFIGURATION OF THIS PRODUCT (SCEPTER XC) IS ONLY SOLD IN JAPAN; HOWEVER, IT IS THE SAME AS THE SCEPTER XC THAT IS U.S. APPROVED UNDER 510(K) K121785.

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: THE INVESTIGATION OF THE RETURNED BALLOON CATHETER FOUND THE COILS AT THE PROXIMAL END OF THE BALLOON TO BE UNWOUND AND THE YELLOW POLYIMIDE RING DISLODGED WITHIN THE BALLOON NEAR THE UNWOUND COILS, WHICH IS CONSISTENT WITH THE ALLEGED PRODUCT ISSUE. HOWEVER, THE POLYIMIDE RING IS A COMPONENT OF THE DEVICE AND NOT A FOREIGN OBJECT AS DESCRIBED IN THE REPORTED EVENT. THE PHYSICAL EVALUATION OF THE DEVICE COULD NOT IDENTIFY THE EXACT CONDITIONS OR CIRCUMSTANCES THAT LED TO THE POLYIMIDE RING DISLODGING, BUT THIS CONDITION IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES OVER SPECIFICATION DUE TO OVER INFLATION.

    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 REPORTED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RETURNED. THE ALLEGED PRODUCT ISSUE COULD NOT BE CONFIRMED. IF THE DEVICE IS RECEIVED AT A LATER DATE, AN INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    PLEASE SEE SECTION H11 FOR UDI RELATED DATA QUALITY UPDATES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREPARATION OF THE BALLOON, A SMALL BUT VISIBLE YELLOW FOREIGN SUBSTANCE WAS OBSERVED IN THE BALLOON. THE BALLOON WAS NOT USED IN THE PATIENT, AND ANOTHER BALLOON WAS USED FOR THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR HEALTH DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759697 SCEPTER XC BALLOON CATHETER DQY MICROVENTION, INC. MV-BXA41115 0000409162

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown