BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER NEEDLES

    MDR report key: 16361963 · Received February 13, 2023

    Report

    Report Number
    3005099803-2023-00586
    Event Type
    Injury
    Date Received
    February 13, 2023
    Date of Event
    March 1, 2018
    Report Date
    February 14, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GBO
    UDI-DI
    08714729077749
    PMA / PMN Number
    K820867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: DATE OF EVENT: THE EXACT DATE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 2018. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE SUSPECTED LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: IMDRF PATIENT CODES E130501 AND E0506 CAPTURE THE REPORTABLE EVENTS OF ACUTE KIDNEY INJURY AND HEMORRHAGE. IMDRF IMPACT CODES F08, F19 AND F2302 CAPTURE THE REPORTABLE EVENTS OF READMISSION, INTERVENTIONAL RADIOLOGY EMBOLIZATION AND TRANSFUSION.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: THE EXACT DATE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 2018. THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE SUSPECTED LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. IMDRF PATIENT CODES E130501 AND E0506 CAPTURE THE REPORTABLE EVENT OF ACUTE KIDNEY INJURY AND HEMORRHAGE. IMDRF IMPACT CODES F08, F19 AND F23 CAPTURE THE REPORTABLE EVENTS OF READMISSION, INTERVENTIONAL RADIOLOGY EMBOLIZATION AND TRANSFUSION.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A RIGHT PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2018. THE PATIENT EXPERIENCED HEMORRHAGE AND ACUTE KIDNEY INJURY (AKI), REQUIRING READMISSION, INTERVENTIONAL RADIOLOGY (IR) EMBOLIZATION AND TRANSFUSION.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A RIGHT PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2018. THE PATIENT EXPERIENCED HEMORRHAGE AND ACUTE KIDNEY INJURY (AKI). THE PATIENT HAD TO BE READMITTED AND REQUIRED INTERVENTIONAL RADIOLOGY EMBOLIZATION AND TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703879 INTRODUCER NEEDLES CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO BOSTON SCIENTIFIC CORPORATION M0067001210 08714729077749

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention| H