BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPYGLASS DISCOVER DIGITAL CATHETER

    MDR report key: 14435269 · Received May 19, 2022

    Report

    Report Number
    3005099803-2022-02739
    Event Type
    Injury
    Date Received
    May 19, 2022
    Date of Event
    April 21, 2022
    Report Date
    July 14, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729994183
    PMA / PMN Number
    K200483
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE : NTN. INITIAL REPORTER ADDRESS: (B)(6). (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE PROBLEM 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

    ADDITIONAL INFORMATION: BLOCK B2 (OUTCOMES ATTRIB TO ADV EVENT), BLOCK B5 (DESCRIBE EVENT OR PROBLEM). BLOCK H6 (IMPACT CODES). BLOCK D2B: PRO CODE NTN. BLOCK E1 (INITIAL REPORTER ADDRESS 1): (B)(6). BLOCK H6 (PATIENT CODES): THE PATIENT CODE E0306 CAPTURES THE REPORTABLE EVENT OF PATIENT SEPSIS. BLOCK H6 (EVALUATION CONCLUSION CODES): 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 PROBLEM ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DISCOVER CATHETER WAS USED IN THE BILIARY TRACT DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC) PROCEDURE PERFORMED ON (B)(6) 2022. ON (B)(6) 2022, THE SPYGLASS DISCOVER CATHETER WAS ADVANCED TO THE TARGET AND THE TARGET LESIONS OR STONES WERE VISUALIZED. A GUIDEWIRE WAS USED TO ADVANCE THE SPY DISCOVER CATHETER DURING THE PROCEDURE. A DILATATION BALLOON WAS USED AND THE BILIARY STONES WAS CLEARED USING AN AUTOLITH FOR LITHOTRIPSY. A 10F INTRADUCTAL DRAIN REMAINED IN PLACE FOR THE SAFETY OF THE PATIENT. ON (B)(6) 2022, THE PATIENT EXPERIENCED MODERATE SEPSIS WITH FEVER AND PRESENCE OF HIGH INFLAMMATORY MARKERS (WHITE BLOOD COUNT, PROCALCITONIN, PCR) AND ON BLOOD TEST RESULTS. THE PATIENT WAS HOSPITALIZED AND ANTIBIOTICS WERE ADMINISTERED (TAZOCIN).

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DISCOVER CATHETER WAS USED IN THE BILIARY TRACT DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC) PROCEDURE PERFORMED ON (B)(6), 2022. ON (B)(6), 2022, THE SPYGLASS DISCOVER CATHETER WAS ADVANCED TO THE TARGET AND THE TARGET LESIONS OR STONES WERE VISUALIZED. A GUIDEWIRE WAS USED TO ADVANCE THE SPY DISCOVER CATHETER DURING THE PROCEDURE. A DILATATION BALLOON WAS USED AND THE BILIARY STONES WAS CLEARED USING AN AUTOLITH FOR LITHOTRIPSY. A 10F INTRADUCTAL DRAIN REMAINED IN PLACE FOR THE SAFETY OF THE PATIENT. ON (B)(6), 2022, THE PATIENT EXPERIENCED MODERATE SEPSIS WITH FEVER AND PRESENCE OF HIGH INFLAMMATORY MARKERS (WHITE BLOOD COUNT, PROCALCITONIN, PCR) AND ON BLOOD TEST RESULTS. THE PATIENT WAS HOSPITALIZED AND ANTIBIOTICS WERE ADMINISTERED (TAZOCIN). ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 17, 2022: THE PHYSICIAN STATED THAT IT IS TYPICAL TO HOSPITALIZE PATIENTS AS STANDARD OF CARE FOR FOUR TO FIVE DAYS AND THAT THERE WAS NO DELAYED DISCHARGE DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1892613 SPYGLASS DISCOVER DIGITAL CATHETER FBN BOSTON SCIENTIFIC CORPORATION M00546780 0028513393 08714729994183

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Hospitalization| R