BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMAGER II UROLOGY TORQUEABLE CATHETER

    MDR report key: 16709990 · Received April 10, 2023

    Report

    Report Number
    3005099803-2023-01834
    Event Type
    Injury
    Date Received
    April 10, 2023
    Date of Event
    July 1, 2019
    Report Date
    May 2, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOD
    UDI-DI
    08714729430261
    PMA / PMN Number
    K102527
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: THE EXACT DATE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 2019. THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE SUSPECTED LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. ADVERSE EVENT PROBLEM: IMDRF PATIENT CODE E010701 CAPTURES THE REPORTABLE EVENT OF DELIRIUM. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF READMISSION.

    Additional Manufacturer Narrative · 0

    BLOCK B3: DATE OF EVENT: THE EXACT DATE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN JULY 2019. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE SUSPECTED LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H2: ADDITIONAL INFORMATION: BLOCK B5 (DESCRIBE EVENT OR PROBLEM) HAS BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON APRIL 3, 2023. BLOCK H6: IMDRF PATIENT CODE E010701 CAPTURES THE REPORTABLE EVENT OF DELIRIUM. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF READMISSION.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, 8/10 DILATOR SHEATH SET AND PERCUTANEOUS ACCESS NEEDLE WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN (B)(6) 2019. THE PATIENT EXPERIENCED DELIRIUM AND WAS READMITTED. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS NOT RELATED TO THE IMAGER II AND 8/10 DILATOR SHEATH SET BUT WAS PROBABLY RELATED TO THE PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS POSSIBLY RELATED TO THE PERCUTANEOUS ACCESS NEEDLE BUT WAS PROBABLY RELATED TO THE PROCEDURE.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II AND 8/10 DILATOR SHEATH SET WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN (B)(6)2019. THE PATIENT EXPERIENCED DELIRIUM AND WAS READMITTED. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS NOT RELATED TO THE IMAGER II AND 8/10 DILATOR SHEATH SET BUT WAS PROBABLY RELATED TO THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON APRIL 3, 2023: IT WAS CLARIFIED THAT A PERCUTANEOUS ACCESS NEEDLE WAS NOT USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1853294 IMAGER II UROLOGY TORQUEABLE CATHETER CATHETER, UROLOGICAL KOD BOSTON SCIENTIFIC CORPORATION M0064003001 08714729430261

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Hospitalization