BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEZOID¿ RX

    MDR report key: 3090031 · Received May 2, 2013

    Report

    Report Number
    3005099803-2013-03457
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF TIP FAILED TO DETACH. (B)(4) FOR THE REPORTED EVENT OF HANDLE BREAK. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING A STONE REMOVAL PROCEDURE WITHIN THE PANCREAS, PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS REPORTED TO HAVE RENAL INSUFFICIENCY, PANCREATITIS, RESPIRATORY FAILURE, AND MELENA. FURTHERMORE, THE PATIENT SUFFERED WITH A FISTULA ON THE PANCREAS; STENOSIS AND CALCULUS WERE ALSO NOTED. DURING THE PROCEDURE, STONES WERE CAPTURED FROM THE PANCREAS SUCCESSFULLY AND THEN LITHOTRIPSY WAS ATTEMPTED; HOWEVER, THE BASKET FAILED TO CRUSH THE STONE. DUE TO A STENOSIS, THE PHYSICIAN WAS UNABLE TO REMOVE THE BASKET WITH THE CAPTURED STONES FROM THE PATIENT. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE TIP OF THE BASKET IN ORDER TO RELEASE THE STONES, BUT THE TIP FAILED TO DETACH FROM THE BASKET ASSEMBLY AND THE HANDLE DETACHED. AFTER 45 MINUTES THE PHYSICIAN WAS ABLE TO REMOVE THE BASKET FROM THE PATIENT. THE PROCEDURE WAS COMPLETED BY PLACING ONE "VBP" PROSTHESIS IN THE BILE DUCT, AND ONE "VBP" PROSTHESIS IN THE PANCREAS. DUE TO THE PROLONGED PROCEDURE OF OVER TWO HOURS, THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE FOR TREATMENT FOR RESPIRATORY FAILURE AND MELENA. THE PATIENT'S CONDITION STABILIZED AND IS NOW IN THE SAME CONDITION AS SHE WAS PRIOR TO THE PROCEDURE. IT IS UNKNOWN IF THE PATIENT HAS BEEN RELEASED FROM THE HOSPITAL. ADDITIONALLY, THIS DEVICE IS NOT INDICATED FOR USE WITHIN THE PANCREATIC DUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192412 TRAPEZOID¿ RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510860 15217796

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R