BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COREDX

    MDR report key: 19633247 · Received June 28, 2024

    Report

    Report Number
    3005099803-2024-03020
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    June 3, 2024
    Report Date
    October 22, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729971054
    PMA / PMN Number
    K183085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 H11: IMDRF DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF JAWS FAILURE TO CLOSE.

    Additional Manufacturer Narrative · 0

    BLOCK H2 (ADDITIONAL INFORMATION): BLOCKS D4, E1, E2, E3, H4 AND H10 WERE UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON JULY 26, 2024. BLOCK H11: IMDRF DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF JAWS FAILURE TO CLOSE.

    Additional Manufacturer Narrative · 0

    BLOCK H2 (ADDITIONAL INFORMATION): BLOCKS D4, E1, E2, E3, H4 AND H10 WERE UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON JULY 26, 2024. BLOCK H6: IMDRF DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF JAWS FAILURE TO CLOSE. BLOCK H11: INVESTIGATION RESULTS THE RETURNED COREDX BIOPSY FORCEPS WAS RECEIVED FOR ANALYSIS. VISUAL AND MICROSCOPE INSPECTION REVEALED THAT ONE LINK WAS DETACHED FROM THE CORE WIRE ATTACHMENT. DUE TO THIS CONDITION THE JAWS WERE UNABLE TO OPEN AND CLOSE. MEDIA ANALYSIS OF A VIDEO PROVIDED BY THE ACCOUNT ALSO SHOWED THE DEVICE BEING UNABLE TO OPEN AND CLOSE. THE REPORTED EVENT WAS CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE INVESTIGATION FINDING OF LINK DETACHED WAS MOST LIKELY GENERATED DUE TO PROCEDURAL FACTORS SUCH AS LESION CHARACTERISTICS, HANDLING OF THE DEVICE, THE TECHNIQUE USED BY THE PHYSICIAN, OR NORMAL PROCEDURAL DIFFICULTIES. THEREFORE, IT IS POSSIBLE THAT FACTORS AND/OR CONDITIONS RELATED TO PROCEDURE DURING THE USE OF THE DEVICE COULD HAVE AFFECTED ITS PERFORMANCE AND ITS INTENDED PURPOSE, LEADING TO THE REPORTED EVENT. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU)/PRODUCT LABEL.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DIFFERENT CORE DX DEVICES USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX BIOPSY FORCEPS WAS USED IN THE LN7 DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING PROCEDURE, THE CUPS FAILED TO CLOSE AND HAD UNEVEN OPENING. A SECOND COREDX BIOPSY FORCEPS WAS TRIED AND THE SAME PROBLEM HAPPENED. THE PROCEDURE WAS COMPLETED WITH A THIRD COREDX BIOPSY FORCEPS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: A PHOTO AND VIDEO OF THE DEVICE OUTSIDE THE PATIENT WAS PROVIDED SHOWING THE JAWS WITH UNEVEN OPENING AND FAILING TO CLOSE.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DIFFERENT CORE DX DEVICES USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX BIOPSY FORCEPS WAS USED IN THE LN7 DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING PROCEDURE, THE CUPS FAILED TO CLOSE AND HAD UNEVEN OPENING. A SECOND COREDX BIOPSY FORCEPS WAS TRIED AND THE SAME PROBLEM HAPPENED. THE PROCEDURE WAS COMPLETED WITH A THIRD COREDX BIOPSY FORCEPS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: A PHOTO AND VIDEO OF THE DEVICE OUTSIDE THE PATIENT WAS PROVIDED SHOWING THE JAWS WITH UNEVEN OPENING AND FAILING TO CLOSE.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DIFFERENT CORE DX DEVICES USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX BIOPSY FORCEPS WAS USED IN THE LN7 DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING PROCEDURE, THE CUPS FAILED TO CLOSE AND HAD UNEVEN OPENING. A SECOND COREDX BIOPSY FORCEPS WAS TRIED AND THE SAME PROBLEM HAPPENED. THE PROCEDURE WAS COMPLETED WITH A THIRD COREDX BIOPSY FORCEPS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: A PHOTO AND VIDEO OF THE DEVICE OUTSIDE THE PATIENT WAS PROVIDED SHOWING THE JAWS WITH UNEVEN OPENING AND FAILING TO CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2215597 COREDX BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00515220 0032353641 08714729971054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown