BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYGLASS DISCOVER DIGITAL CATHETER

    MDR report key: 14793834 · Received June 23, 2022

    Report

    Report Number
    3005099803-2022-03473
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    February 8, 2022
    Report Date
    July 7, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729994183
    PMA / PMN Number
    K200483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PROCODE: NTN. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4). 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 A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    D2B (PRODUCT CODE): NTN. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6 (IMPACT CODES): IMPACT CODE F2301 AND F19 ARE BEING USED TO CAPTURE THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED AND SURGICAL INTERVENTION PROCEDURE. BLOCK H6: 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 A SUPPLEMENTAL MDR WILL BE FILED. BLOCK H11: ADDITIONAL INFORMATION E1 (INITIAL REPORTER FIRST NAME AND INITIAL REPORTER LAST NAME).

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO TWO SPYGLASS DISCOVER CATHETERS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPYGLASS DISCOVER CATHETERS WERE USED DURING A LAPAROSCOPIC TRANSCYSTIC COMMON BILE DUCT EXPLORATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE FIRST SPYGLASS DISCOVER CATHETER WAS IN USE FOR ABOUT 40 MINUTES AND THEN THERE WAS LOSS OF VISUALIZATION. A SECOND SPYGLASS DISCOVER CATHETER WAS IN USE ALONG WITH AN ELECTROHYDRAULIC LITHOTRIPSY (EHL) PROBE FOR APPROXIMATELY FIVE MINUTES. THEN THE IMAGE BECAME INTERMITTENTLY DISTORTED AND FROZE. THE PROCEDURE WAS CONVERTED TO A CHOLEDOCHOTOMY AND COMPLETED USING A NON-BSC SCOPE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO TWO SPYGLASS DISCOVER CATHETERS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPYGLASS DISCOVER CATHETERS WERE USED DURING A LAPAROSCOPIC TRANSCYSTIC COMMON BILE DUCT EXPLORATION PROCEDURE PERFORMED ON FEBRUARY 8, 2022. DURING THE PROCEDURE, THE FIRST SPYGLASS DISCOVER CATHETER WAS IN USE FOR ABOUT 40 MINUTES AND THEN THERE WAS LOSS OF VISUALIZATION. A SECOND SPYGLASS DISCOVER CATHETER WAS IN USE ALONG WITH AN ELECTROHYDRAULIC LITHOTRIPSY (EHL) PROBE FOR APPROXIMATELY FIVE MINUTES. THEN THE IMAGE BECAME INTERMITTENTLY DISTORTED AND FROZE. THE PROCEDURE WAS CONVERTED TO A CHOLEDOCHOTOMY AND COMPLETED USING A NON-BSC SCOPE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328730 SPYGLASS DISCOVER DIGITAL CATHETER FBN BOSTON SCIENTIFIC CORPORATION M00546780 08714729994183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown