BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE2L

    MDR report key: 9747878 · Received February 24, 2020

    Report

    Report Number
    3014162263-2020-00004
    Event Type
    Injury
    Date Received
    February 24, 2020
    Date of Event
    January 28, 2020
    Report Date
    February 24, 2020
    Manufacturer
    BALT USA, LLC
    Product Code
    MJN
    UDI-DI
    00818053022982
    PMA / PMN Number
    K183045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO WHOM IT MAY CONCERN: ON (B)(6) 2020, BALT USA RECEIVED A COMPLAINT REGARDING THE USE OF A SINGLE ECLIPSE2L. DETAILS REPORTED AS FOLLOWS: "DURING EMBOLIZATION OF SPINAL ARTERY, MD OVER INFLATED THE ECLIPSE DUAL LUMEN BALLOON BEYOND WHAT WAS RECOMMENDED FOR THE SIZE OF THE ARTERY. THE BALLOON CAUSED A RUPTURE OF THE ANTERIOR SPINAL ARTERY. THE MD PLACED COILS THROUGH THE BALLOON TO SHUT DOWN THE VESSEL. THE MD THEN INJECTED SOME ONYX THROUGH THE ECLIPSE. THE PROCEDURE SEEMED SUCCESSFUL UNTIL HE TRIED TO REMOVE THE ECLIPSE. THERE APPEARED TO BE A CHUNK OF ONYX (AND COIL) THAT STUCK TO THE BALLOON CATHETER TIP WHEN WITHDRAWING. HE STOPPED WITHDRAWAL AND ATTEMPTED TO ADVANCE THE INTERMEDIATE CATHETER (CAT5) INTO THE ASA TO CAPTURE THE ONYX AND COIL. THE CAT5 COULD NOT GET INTO THE ASA. HE CONTINUED TO WITHDRAW THE ECLIPSE AND THE CHUNK OF ONYX AND COIL DISLODGED FROM THE ECLIPSE TIP. UPON FOLLOW-UP THERE DID NOT SEEM TO BE A NEGATIVE IMPACT ON THE PATIENT'S STATUS AS A RESULT OF THE PROCEDURAL COMPLICATION." THE RESULTS OF OUR INVESTIGATION FOLLOWING RETURN OF THE AFFECTED DEVICE, ARE SUMMARIZED AS FOLLOWS: AN EVALUATION OF THE ACTUAL COMPLAINT SAMPLE COULD NOT BE PERFORMED DEVICE WAS REPORTED UNAVAILABLE. BASED ON THE PROVIDED INFORMATION, ROOT CAUSE CAN BE ATTRIBUTED TO USER ERROR AS THE DEVICE WAS INFLATED BEYOND THE RECOMMENDED SIZE OF THE ARTERY. REVIEW OF THE LOT HISTORY RECORDS FOR THE REPORTED LOTS DID NOT REVEAL ANY IN-PROCESS OR LOT-SPECIFIC ISSUE THAT COULD ACCOUNT FOR THE OBSERVATION. NO ADDITIONAL COMPLAINTS AGAINST LOT NUMBER F191200103 HAS BEEN MADE FOR THE SAME ISSUE. COMPREHENSIVE ANALYSIS OF THIS FAILURE MODE HAS REMAINED SUBJECT TO MONITORING FOR ANY UNACCEPTABLE INCREASE IN TREND. 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 · 1

    IT WAS REPORTED THAT: "DURING EMBOLIZATION OF SPINAL ARTERY, MD OVER INFLATED THE ECLIPSE DUAL LUMEN BALLOON BEYOND WHAT WAS RECOMMENDED FOR THE SIZE OF THE ARTERY. THE BALLOON CAUSED A RUPTURE OF THE ANTERIOR SPINAL ARTERY. THE MD PLACED COILS THROUGH THE BALLOON TO SHUT DOWN THE VESSEL. THE MD THEN INJECTED SOME ONYX THROUGH THE ECLIPSE. THE PROCEDURE SEEMED SUCCESSFUL UNTIL HE TRIED TO REMOVE THE ECLIPSE. THERE APPEARED TO BE A CHUNK OF ONYX (AND COIL) THAT STUCK TO THE BALLOON CATHETER TIP WHEN WITHDRAWING. HE STOPPED WITHDRAWAL AND ATTEMPTED TO ADVANCE THE INTERMEDIATE CATHETER (CAT5) INTO THE ASA TO CAPTURE THE ONYX AND COIL. THE CAT5 COULD NOT GET INTO THE ASA. HE CONTINUED TO WITHDRAW THE ECLIPSE AND THE CHUNK OF ONYX AND COIL DISLODGED FROM THE ECLIPSE TIP. UPON FOLLOW-UP THERE DID NOT SEEM TO BE A NEGATIVE IMPACT ON THE PATIENT'S STATUS AS A RESULT OF THE PROCEDURAL COMPLICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208709 ECLIPSE2L ECLIPSE2L MJN BALT USA, LLC ECL2L6X15 F191200103 00818053022982

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R