BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOBBY 8F BALLOON GUIDE CATHETER

    MDR report key: 13999576 · Received April 4, 2022

    Report

    Report Number
    2032493-2022-00120
    Event Type
    Death
    Date Received
    April 4, 2022
    Date of Event
    March 6, 2022
    Report Date
    March 8, 2022
    Manufacturer
    MICROVENTION, INC.
    Product Code
    QJP
    UDI-DI
    00842429108550
    PMA / PMN Number
    K193607
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 AND THE INVESTIGATION IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETED. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES VESSEL DISSECTION AND DEATH AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    CORRECTION: G3 (DATE RECEIVED BY MANUFACTURER: 08-MAR-2022).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN STATED THAT INFARCT-RELATED CRITICAL SWELLING OR INTRACEREBRAL HEMATOMA HAVE BEEN RULED OUT AT THE TIME OF THE LAST IMAGING. CLINICAL STATUS BEFORE THROMBECTOMY WAS: "PATIENT SOPORIFIC, DOES NOT OPEN EYES, BULBI MOVE CONJUGATELY, CORNEAL REFLEX CANNOT BE TRIGGERED RELIABLY, SPONTANEOUS MOVEMENT OF THE RIGHT HALF OF THE BODY, SPONTANEOUS BABINSKI RIGHT, BABINSKI LEFT POSITIVE." SUMMARY DEVICE EVALUATION: THE INVESTIGATION OF THE RETURNED BALLOON CATHETER SYSTEM FOUND NO DAMAGE ALONG THE BODY OR ANYWHERE ON THE DEVICE THAT COULD HAVE LED TO A DISSECTION OF THE PATIENT'S ICA OR THAT COULD HAVE HINDERED THE DEVICE FROM FUNCTIONING AS INTENDED. INFLATION TESTING WAS PERFORMED AND FOUND THE BALLOON WAS ABLE TO SUCCESSFULLY INFLATE WITH NO ISSUES. THE CATHETER USED IN THE PROCEDURE IN TANDEM WITH THE BOBBY DEVICE WAS NOT EVALUATED AS A PART OF THIS EVALUATION, THEREFORE, THE INVESTIGATION COULD NOT DETERMINE IF IT HAD CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A COMPLICATION OCCURRED DURING TREATMENT OF AN M2R AND A2L OCCLUSION. THE PATIENT WAS (B)(6) YEARS AND HOSPITALIZED DUE TO A FEMORAL FRACTURE IN THE SETTING OF MULTIPLE HIGH GRADE INTRACRANIAL STENOSIS. A THROMBECTOMY WAS INITIALLY PLANNED BUT COULD NOT BE PERFORMED DUE TO THE EXTENSIVE STENOSIS. DURING THE PROCEDURE, A (B)(6) BALLOON CATHETER WAS INSERTED, BUT NEVER INFLATED. A DISSECTION OF THE PROXIMAL LEFT CIA WAS OBSERVED DURING THE FIRST ANGIOGRAM AND THE CAUSE OF THE DISSECTION IS UNKNOWN. REPORTEDLY, THE PATIENT PASSED AWAY A FEW DAYS LATER DUE TO "CENTRAL REGULATORY FAILURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166763 BOBBY 8F BALLOON GUIDE CATHETER PERCUTANEOUS CATHETHER QJP MICROVENTION, INC. BOB-895-EMEA 0000106565 00842429108550

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Death| L