BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERJECT

    MDR report key: 22088046 · Received May 27, 2025

    Report

    Report Number
    3005099803-2025-02325
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    April 29, 2025
    Report Date
    June 18, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCG
    UDI-DI
    08714729415091
    PMA / PMN Number
    K012864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF THE NEEDLE DETACHED FROM THE SHEATH.

    Additional Manufacturer Narrative · 0

    BLOCK G4: ADDITIONAL PREMARKET / 510(K) #: K171454. BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF THE NEEDLE DETACHED FROM THE SHEATH. BLOCK H11: THE DEVICE WAS NOT RETURNED, HOWEVER, MEDIA ANALYSIS FOUND THAT THE HANDLE DETACHED. BASED ON ALL AVAILABLE INFORMATION, THE PRODUCT WAS NOT RETURNED FOR ANALYSIS TO IDENTIFY ANY DEFECT WITH THE DEVICE. ADDITIONALLY, WITHOUT PROPER EVALUATION OF THE DEVICE, IT REMAINS UNKNOWN THE MOST PROBABLE CAUSES THAT CONTRIBUTED TO THE EVENT. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE CAUSE IS CAUSE NOT ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT NEEDLE WAS USED IN THE POLYPS DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SHEATH. ANOTHER INTERJECT NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT NEEDLE WAS USED IN THE POLYPS DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SHEATH. ANOTHER INTERJECT NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333491 INTERJECT BIOPSY NEEDLE FCG BOSTON SCIENTIFIC CORPORATION M00518250 0034205937 08714729415091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown