BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088

    MDR report key: 1972578 · Received January 28, 2011

    Report

    Report Number
    3005099803-2011-00056
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    November 22, 2010
    Report Date
    January 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: FUJIFILM SCOPE. SIDE-CAR PUSH-BACK. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE FULL LENGTH OF THE GUIDEWIRE LUMEN (SIDE-CAR) TO BE SPLIT AND PRESENTED PUSH-BACK. THE RETURNED UNIT WAS FUNCTIONALLY TESTED BY EXTENDING THE BASKET AND IT PERFORMED ACCORDING TO SPECIFICATIONS. NO DEFORMITIES WERE FOUND WITH THE GUIDEWIRE LUMEN (SIDE-CAR) WHICH WOULD HAVE CAUSED DIFFICULTY INSERTING THE GUIDEWIRE THROUGH THE LUMEN. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT, GUIDEWIRE PASSAGE RESTRICTION. HOWEVER, DURING DEVICE EVALUATION, IT WAS FOUND THAT THE GUIDEWIRE LUMEN (SIDE-CAR) TO BE SPLIT AND PRESENTED PUSH-BACK. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS EXCESSIVE FORCE MAY HAVE BEEN APPLIED TO THE DEVICE DUE TO ANATOMICAL OR PROCEDURAL FACTORS, DAMAGING THE GUIDEWIRE LUMEN. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING A BILE DUCT STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN FELT THAT THE TIP OF THE DEVICE WAS SOFTER THAN USUAL. REPORTEDLY, THE GUIDEWIRE COULD NOT PASS THROUGH THE GUIDEWIRE LUMEN PORT. NO PRODUCT DAMAGE WAS NOTED OR REPORTED, AND THE PROCEDURE WAS COMPLETED WITH THIS TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET DEVICE. ADDITIONALLY, IT WAS REPORTED THAT THE CUSTOMER NORMALLY USES A PENTAX SCOPE, HOWEVER, DURING THIS PROCEDURE A FUJIFILM SCOPE WAS USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; SIDE-CAR TORN AND PUSH-BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510880 13468555

    Patients

    Seq Age Sex Outcome Treatment
    1