BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX LOCKING DEVICE AND BIOPSY CAP

    MDR report key: 20359266 · Received October 3, 2024

    Report

    Report Number
    3005099803-2024-04947
    Event Type
    Malfunction
    Date Received
    October 3, 2024
    Date of Event
    August 23, 2024
    Report Date
    October 21, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ODC
    UDI-DI
    08714729746676
    PMA / PMN Number
    K010610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G2: THE VOLUNTARY USER MEDWATCH NUMBER IS (B)(4). BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF THE SPONGE DETACHED.

    Additional Manufacturer Narrative · 0

    BLOCK G2: THE VOLUNTARY USER MEDWATCH NUMBER IS (B)(4). BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF THE SPONGE DETACHED. H2: CORRECTION MADE TO H10, RELATED MEDWATCH 3500A REPORT NUMBER ADDED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING / BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT FOR THE TREATMENT OF DILATED COMMON BILE DUCT AND STONE REMOVAL ON (B)(6) 2024. DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN WAS UNABLE TO PASS INSTRUMENTS THROUGH THE WORKING CHANNEL OF THE SCOPE. THEY WERE ALSO UNABLE TO INSTILL CONTRAST VIA DREAMTOME. THEY SWITCHED TO A NEW SCOPE, WHICH WAS SUCCESSFULLY USED AFTER A FIFTEEN MINUTE DELAY. REPORTEDLY, DURING REPROCESSING, AN ENDO TECH DISCOVERED A SPONGE LODGED IN THE WORKING CHANNEL, IDENTIFIED AS PART OF THE RX LOCKING/BIOPSY CAP. THE FOAM PIECE WAS REMOVED BY PUSHING MULTIPLE BRUSHES DOWN THE BIOPSY CHANNEL. A WATER-SOLUBLE LUBRICANT WAS NOT APPLIED TO THE TOP OF THE BIOPSY CAP, PRIOR TO USE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING / BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT FOR THE TREATMENT OF DILATED COMMON BILE DUCT AND STONE REMOVAL ON (B)(6) 2024. DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN WAS UNABLE TO PASS INSTRUMENTS THROUGH THE WORKING CHANNEL OF THE SCOPE. THEY WERE ALSO UNABLE TO INSTILL CONTRAST VIA DREAMTOME. THEY SWITCHED TO A NEW SCOPE, WHICH WAS SUCCESSFULLY USED AFTER A FIFTEEN MINUTE DELAY. REPORTEDLY, DURING REPROCESSING, AN ENDO TECH DISCOVERED A SPONGE LODGED IN THE WORKING CHANNEL, IDENTIFIED AS PART OF THE RX LOCKING/BIOPSY CAP. THE FOAM PIECE WAS REMOVED BY PUSHING MULTIPLE BRUSHES DOWN THE BIOPSY CHANNEL. A WATER-SOLUBLE LUBRICANT WAS NOT APPLIED TO THE TOP OF THE BIOPSY CAP, PRIOR TO USE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870070 RX LOCKING DEVICE AND BIOPSY CAP ENDOSCOPE CHANNEL ACCESSORY ODC BOSTON SCIENTIFIC CORPORATION M00545260 0033786468 08714729746676

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female