BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCCLUDER

    MDR report key: 12672029 · Received October 21, 2021

    Report

    Report Number
    3005099803-2021-05291
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 21, 2021
    Report Date
    January 5, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EYB
    UDI-DI
    08714729192008
    PMA / PMN Number
    K133750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H2: ADDITIONAL INFORMATION: BLOCK B5 (DESCRIBE EVENT OR PROBLEM), BLOCK D7 (SUD REPROCESSED AND REUSED), H6 (DEVICE CODES) AND BLOCK H8 (USAGE OF DEVICE). 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. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A0402 CAPTURES THE REPORTABLE INVESTIGATION FINDINGS OF BALLOON BURST. BLOCK H10: INVESTIGATION RESULT A VISUAL EXAMINATION OF THE RETURNED COMPLAINT DEVICE FOUND THE BALLOON WAS RUPTURED, THEREBY CONFIRMING THE REPORTED EVENT OF BALLOON WOULD NOT INFLATE. THE BALLOON LUMEN AND THE DISTAL LUMEN WERE IN A GOOD SHAPE. ADDITIONALLY, THE STOPCOCK WAS RETURNED WITH THE DEVICE. FUNCTIONAL EVALUATION COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THIS PROBLEM IS LIKELY DUE TO FACTORS ENCOUNTERED DURING THE PROCEDURE, SUCH AS THE INFLATION OF THE BALLOON OR THE INSERTION OF THE BALLOON THROUGH THE SCOPE COULD HAVE AFFECTED THE DEVICE PERFORMANCE AND ITS INTENDED PURPOSE, LEADING TO THE FOUND PROBLEM OF BALLOON BURST. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE BECAUSE THE ADVERSE EVENT OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU)/PRODUCT LABEL.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED DURING A KIDNEY STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON HAVE DEFLATION PROBLEMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUDER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS REPORT PERTAINS TO ONE OF TWO OCCLUDER BALLOON CATHETERS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED THAT BOTH BALLOONS DID NOT HAVE DEFLATION PROBLEMS BUT INSTEAD WOULD JUST NOT INFLATE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED DURING A KIDNEY STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON HAVE DEFLATION PROBLEMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUDER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 13, 2021: NOTE: THIS REPORT PERTAINS TO ONE OF TWO OCCLUDER BALLOON CATHETERS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED THAT BOTH BALLOONS DID NOT HAVE DEFLATION PROBLEMS BUT INSTEAD WOULD JUST NOT INFLATE.

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED DURING A KIDNEY STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON HAVE DEFLATION PROBLEMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUDER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568674 OCCLUDER CATHETER, UROLOGICAL EYB BOSTON SCIENTIFIC CORPORATION M0062201090 0027062049 08714729192008

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown