BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLAST LONG SHEATH

    MDR report key: 8634466 · Received May 22, 2019

    Report

    Report Number
    3014162263-2019-00005
    Event Type
    Injury
    Date Received
    May 22, 2019
    Date of Event
    April 23, 2019
    Report Date
    May 22, 2019
    Manufacturer
    BALT USA, LLC
    Product Code
    DQY
    UDI-DI
    00818053022890
    PMA / PMN Number
    K182918
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT. DEVICE NOT SENT BACK TO MANUFACTURER. WITH BEING UNABLE TO REACH OUT TO THE PHYSICIAN THE COMPLAINT WILL ROUTE TO CLOSE WITH BEING UNABLE TO DETERMINE ROUTE CAUSE. HOWEVER, UPON FURTHER REVIEW BASED ON THE DATA PRESENTED IT SEEMS CURIOUS THAT A BALLOON AS SMALL AS A SCEPTER WOULD NOT TRAVERSE THE PETROUS SEGMENT. THIS SUGGEST SOMETHING IS ANATOMICALLY OUT OF THE ORDINARY. BALLAST HAS NOT BEEN CONFIRMED THE CAUSE OF THE DIFFUSE SHOWERING OF EMBOLI, AND THE TEAM IS THINKING THAT POSSIBLY THERE WAS A PREEXISTING KNOWN DISEASE. IT ALSO SHOULD BE NOTED THAT BALLAST IS DESIGNED AS A CAROTID SHEATH FOR SUPPORT OF ANCILLARY DEVICES. IT IS NOT DESIGNED FOR DISTAL ACCESS. THE SUBMISSION OF THIS REPORT OR RELATED INFORMATION TO THE FDA, AND ITS RELEASE BY FDA, DOES NOT REFLECT A CONCLUSION BY THE PARTY SUBMITTING THIS REPORT OF THE FDA THAT THE REPORT OR RELATED INFORMATION IS AN ADMISSION THAT THE MANUFACTURER, THEIR EMPLOYEES, OR THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "FIRST TIME USE OF BALLAST 90 IN AN AVM PATIENT. DR. (B)(6) ACCESSED THE RIGHT INTERNAL CAROTID BUT COULDN'T GET THE BALLAST TO MOVE INTO THE HORIZONTAL PETROUS SEGMENT OVER A .035 EXCHANGE WIRE. HE THEN ACCESSED THE LEFT INTERNAL CAROTID WITH A .038 GLIDE WIRE AND AGAIN THE BALLAST WOULD NOT TRACK INTO THE HORIZONTAL PETROUS SECTION. HE ALSO TRIED TO ADVANCE OF THE SCEPTER BALLOON 4X11 AND IT STILL WOULDN'T MOVE INTO THE HORIZONTAL PETROUS SECTION. THAT EVENING THE PATIENT EXPERIENCED DIFFUSE SHOWERING OF EMBOLI IN BOTH HEMISPHERES. "

    Additional Manufacturer Narrative · 1

    INITIAL REPORT. DEVICE NOT SENT BACK TO MANUFACTURER. REACHING OUT WITH PHYSICIAN FOR ADDITIONAL INFORMATION TO HELP AN INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "FIRST TIME USE OF BALLAST 90 IN AN AVM PATIENT. DR. (B)(6) ACCESSED THE RIGHT INTERNAL CAROTID BUT COULDN'T GET THE BALLAST TO MOVE INTO THE HORIZONTAL PETROUS SEGMENT OVER A .035 EXCHANGE WIRE. HE THEN ACCESSED THE LEFT INTERNAL CAROTID WITH A .038 GLIDE WIRE AND AGAIN THE BALLAST WOULD NOT TRACK INTO THE HORIZONTAL PETROUS SECTION. HE ALSO TRIED TO ADVANCE OF THE SCEPTER BALLOON 4X11 AND IT STILL WOULDN'T MOVE INTO THE HORIZONTAL PETROUS SECTION. THAT EVENING THE PATIENT EXPERIENCED DIFFUSE SHOWERING OF EMBOLI IN BOTH HEMISPHERES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425032 BALLAST LONG SHEATH BALLAST DQY BALT USA, LLC BALLAST90 120518I 00818053022890

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening