BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCCLUDER

    MDR report key: 13306565 · Received January 20, 2022

    Report

    Report Number
    3005099803-2021-08226
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Date of Event
    November 17, 2021
    Report Date
    March 8, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EYB
    UDI-DI
    08714729192008
    PMA / PMN Number
    K133750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. SHOULD THE DEVICE BECOME AVAILABLE FOR ANALYSIS AND THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. BLOCK H6: MEDICAL DEVICE CODE A0402 CAPTURES THE REPORTABLE EVENT OF BALLOON BURST. EVALUATION CONCLUSION CODE D17 IS BEING USED IN LIEU OF AN ADEQUATE CONCLUSION CODE FOR DEVICE NOT RETURNED. BLOCK H10: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. SHOULD THE DEVICE BECOME AVAILABLE FOR ANALYSIS AND THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER DEVICE WAS USED BELOW THE PELVIC URETERIC JUNCTION (PUJ) DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE POSITION OF THE PATIENT WAS CHANGED FROM SUPINE TO PRONE, THE BALLOON WAS CONFIRMED TO BE INFLATED UNDER X-RAY; HOWEVER, IT WAS NOTICED THAT THE CONTRAST WAS LEAKING FROM THE BALLOON A MOMENT AFTER. THE DEVICE WAS THEN REMOVED FROM THE PATIENT AND IT WAS FOUND THAT THE BALLOON BURST. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER DEVICE WAS USED BELOW THE PELVIC URETERIC JUNCTION (PUJ) DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE POSITION OF THE PATIENT WAS CHANGED FROM SUPINE TO PRONE, THE BALLOON WAS CONFIRMED TO BE INFLATED UNDER X-RAY; HOWEVER, IT WAS NOTICED THAT THE CONTRAST WAS LEAKING FROM THE BALLOON A MOMENT AFTER. THE DEVICE WAS THEN REMOVED FROM THE PATIENT AND IT WAS FOUND THAT THE BALLOON BURST. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 10, 2022: THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUDER BALLOON CATHETER DEVICE AND THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THE PHOTOS SUBMITTED BY THE CUSTOMER CONFIRMED THAT THE BALLOON WAS BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490135 OCCLUDER CATHETER, UROLOGICAL EYB BOSTON SCIENTIFIC CORPORATION M0062201090 0026443498 08714729192008

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown