BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEZOID RX

    MDR report key: 19594116 · Received June 24, 2024

    Report

    Report Number
    3005099803-2024-02932
    Event Type
    Injury
    Date Received
    June 24, 2024
    Date of Event
    May 31, 2024
    Report Date
    June 24, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LQC
    UDI-DI
    08714729296379
    PMA / PMN Number
    K040447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKS 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: IMDRF DEVICE CODE A1204 CAPTURES THE REPORTABLE EVENT OF BASKET FAILURE TO RELEASE FOREIGN BODY. IMDRF DEVICE CODE A150301 CAPTURES THE REPORTABLE EVENT OF TIP FAILURE TO SEPARATE. IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF BASKET WIRE BREAK. IMDRF IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGICAL INTERVENTION. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION OR PROLONGED HOSPITALIZATION.

    Additional Manufacturer Narrative · 0

    BLOCKS 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: IMDRF DEVICE CODE A1204 CAPTURES THE REPORTABLE EVENT OF BASKET FAILURE TO RELEASE FOREIGN BODY. IMDRF DEVICE CODE A150301 CAPTURES THE REPORTABLE EVENT OF TIP FAILURE TO SEPARATE. IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF BASKET WIRE BREAK. BLOCK H11: THE CONTENT IN BLOCK H6 HAS BEEN UPDATED. IMDRF IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGICAL INTERVENTION. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION OR PROLONGED HOSPITALIZATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRAPEZOID RX WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, A TRAPEZOID RX BASKET WAS USED TO RETRIEVE A MIGRATED NON-BSC PLASTIC STENT; HOWEVER, THE BASKET GOT TRAPPED AROUND THE STENT. THE PATIENT UNDERWENT OPEN SURGERY ON THE SAME DAY TO HAVE THE BASKET REMOVED. THE PATIENT'S CONDITION FOLLOWING THE SURGERY WAS STABLE AND THEY WERE ADMITTED BEYOND THE STANDARD OF CARE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRAPEZOID RX WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, A TRAPEZOID RX BASKET WAS USED TO RETRIEVE A MIGRATED NON-BSC PLASTIC STENT; HOWEVER, THE BASKET GOT TRAPPED AROUND THE STENT. THE PATIENT UNDERWENT OPEN SURGERY ON THE SAME DAY TO HAVE THE BASKET REMOVED. THE PATIENT'S CONDITION FOLLOWING THE SURGERY WAS STABLE AND THEY WERE ADMITTED BEYOND THE STANDARD OF CARE. NOTE: PHOTOS PROVIDED BY THE CUSTOMER SHOWED AN ENDOSCOPIC IMAGE OF THE DEVICE INSIDE THE PATIENT AND THE DEVICE OUTSIDE THE PATIENT. THE BASKET WIRES ARE BROKEN, AND THE TIP IS STILL ATTACHED. IN ADDITION, THE BROKEN BASKET WIRES AND TIP ARE STUCK WITH THE PLASTIC STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2177904 TRAPEZOID RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC CORPORATION M00510860 08714729296379

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O