BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1882125 · Received October 25, 2010

    Report

    Report Number
    3005099803-2010-04450
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    August 20, 2010
    Report Date
    October 1, 2010
    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: GUIDEWIRE: (B)(4) VISIGLIDE 0.025 INCH. (B)(4), (SIDE-CAR PUSH-BACK). A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND RESIDUE PRESENT INDICATING DEVICE USE. FURTHERMORE, IT WAS NOTED THAT THE SIDE-CAR PRESENTED PUSH-BACK AND WAS COLLAPSED. FUNCTIONALLY A GUIDEWIRE WAS LOADED INTO THE SIDE-CAR BUT WAS UNABLE TO PASS. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT; GUIDEWIRE COULD NOT BE INSERTED. HOWEVER, DURING DEVICE EVALUATION IT WAS NOTED THAT THE SIDE-CAR PRESENTED PUSH-BACK AND WAS COLLAPSED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS IT APPEARS THAT THE SIDECAR BECAME COLLAPSED DURING INSERTION INTO THE SCOPE OR ATTEMPTED USE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. (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 GUIDEWIRE COULD NOT BE INSERTED INTO THE RX PORT OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET DEVICE. REPORTEDLY THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; SIDE-CAR 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 M00510890 13519271

    Patients

    Seq Age Sex Outcome Treatment
    1