BEUDAMED
    FDA Adverse Event Death Summary report: N

    SCEPTER MINI

    MDR report key: 13057266 · Received December 21, 2021

    Report

    Report Number
    2032493-2021-00515
    Event Type
    Death
    Date Received
    December 21, 2021
    Date of Event
    December 1, 2021
    Report Date
    December 2, 2021
    Manufacturer
    MICROVENTION, INC.
    Product Code
    MJN
    UDI-DI
    00816777025821
    PMA / PMN Number
    K110741
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H10 (SUMMARY DEVIDE EVALUATION). SUMMARY OF DEVICE EVALUATION: INVESTIGATION FOUND KINKS ON THE SHAFT OF THE CATHETER, 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. KINKS ON THE SHAFT OF THE CATHETER WOULD RESULT IN DIFFICULTY INFLATING THE BALLOON.

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW, IT WAS NOTED THAT "DEATH" WAS INADVERTENTLY CHECKED IN SECTION H1 IN PREVIOUS SUPPLEMENTAL REPORT. THIS ADDITIONAL SUPPLEMENTAL REPORT IS TO CORRECT THAT ERROR. THERE WAS NO REPORT OF PATIENT DEATH IN THIS EVENT. THE PATIENT WAS REPORTED TO BE WELL, AND NO HARM WAS INCURRED.

    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 EVALUATION. THE ANALYSIS IS CURRENTLY UNDERWAY. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES INTRACEREBRAL/INTRACRANIAL HEMORRHAGE AS A POTENTIAL COMPLICATION ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF A SCEPTER MINI BALLOON CATHETER FOR TREATMENT IN THE MIDDLE MENINGEAL ARTERY FOR SUBDURAL HEMATOMA, BALLOON INFLATION WAS NOT VISUALIZED UNDER FLUORO. A RUN WAS PERFORMED FROM THE GUIDE CATHETER SHOWING THE MIDDLE MENINGEAL ARTERY (MMA) HAD RUPTURED. EMBOLIC MATERIAL WAS USED TO CONTROL THE HEMORRHAGE VERY QUICKLY. THE PATIENT WAS REPORTED TO BE WELL AND NO HARM WAS INCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955354 SCEPTER MINI VASCULAR CLAMP MJN MICROVENTION, INC. BC0210M 210204144 00816777025821

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention