BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEDGEHOG

    MDR report key: 19917103 · Received August 6, 2024

    Report

    Report Number
    3005099803-2024-03713
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 10, 2024
    Report Date
    August 6, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNL
    UDI-DI
    00840253114044
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D4: THIS IS A NON-STERILE DEVICE WITH NO EXPIRATION DATE. BASED ON THE SAS QUERY, THE UPN OF SBD-289 HAS TWO LOT NUMBERS, LOT NUMBER 231117 AND LOT NUMBER 230815. BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF BRUSH BREAK.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DUAL END BRUSH WAS USED DURING A CLEANING PROCEDURE ON AN UNKNOWN DATE. DURING THE CLEANING, THE SCOPE ROOM TECH DID NOT NOTICE THE BRUSH BROKE OFF IN THE SCOPE. DURING A PROCEDURE FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD) ON (B)(6) 2024, THE BIOPSY FORCEPS PUSHED OUT A BROKEN HEDGEHOG CLEANING BRUSH THAT BROKE OFF DURING THE CLEANING PROCEDURE ON THE UNKNOWN DATE. THE BROKEN BRUSH TIP WAS REMOVED WITH A SNARE WHICH CAUSED A LESS THAN 10MM LINEAR TEAR IN THE STOMACH LINING OF THE PATIENT. REPORTEDLY, NO MEDICAL INTERVENTION NEEDED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561926 HEDGEHOG ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE MNL BOSTON SCIENTIFIC CORPORATION SBD-289 00840253114044

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male