BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID¿ RX

    MDR report key: 2221028 · Received August 23, 2011

    Report

    Report Number
    3005099803-2011-02920
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 29, 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

    THE PATIENT WAS REPORTED AS BEING OVER THE AGE OF 18 YEARS. A VISUAL EXAMINATION FOUND THAT THE DEVICE RETURNED WITH THE BASKET IN THE CLOSED POSITION. THE GUIDEWIRE LUMEN (SIDECAR) PRESENTED PUSH-BACK AND THE OUTER SHEATH WAS KINKED/BUCKLED AND TORN AWAY FROM THE DISTAL END OF THE HEATSHRINK. FUNCTIONALLY, THE BASKET WAS NOT ABLE TO BE EXTENDED WITHOUT HOLDING THE SHEATH. WHEN FULLY EXTENDED, THE BASKET WIRES WERE FOUND TO BE EVEN AND UNDEFORMED. ADDITIONALLY, HEAVY RESIDUE WAS PRESENT ON THE BASKET/WIRE ASSEMBLY. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE BASKET WOULD NOT OPEN. HOWEVER, THE EVALUATION ALSO FOUND THAT THE GUIDEWIRE LUMEN (SIDECAR) PRESENTED PUSHBACK, AND THE SHEATH WAS BUCKLED AND TORN. DURING MANUFACTURING, BASKET DEVICES ARE 100% INSPECTED FOR DEVICE INTEGRITY SO THE SIDECAR PUSHBACK LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. ADDITIONALLY, BASED ON THE LOT NUMBER PROVIDED, AN EXPIRATION DATE 07JULY2011 WAS IDENTIFIED FOR THIS DEVICE. AS THE EVENT OCCURRED ON (B)(6) 2011, THE DEVICE WAS USED PAST ITS EXPIRATION DATE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING A STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS NO ISSUE WITH THE BASKET WHEN USED FOR FIRST TIME. WHEN ATTEMPTING TO USE THE BASKET A SECOND TIME TO RETRIEVE A STONE, THE BASKET WOULD NOT OPEN. REPORTEDLY, THERE WAS NO STONE IN THE BASKET WHEN THE BASKET WOULD NOT OPEN. ADDITIONALLY, THE DEVICE WAS TESTED/INSPECTED PRIOR TO USE AND NO ANOMALIES WERE FOUND. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET. 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 REPORTABLE BASED ON THE INVESTIGATION RESULTS; SIDECAR PUSHBACK AND SHEATH TORN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 PULMONARY BIOPSY FORCEPS DEVICE WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE JAWS FAILED TO CLOSE ON THE NINTH PASS. THE USER REPORTED THAT ONE OF THE PULL WIRES APPEARED TO BE DETACHED FROM THE JAW. FLUOROSCOPY WAS USED TO CONFIRM THAT NO PART OF THE DEVICE DETACHED INTO THE PATIENT. AT THIS TIME, THE PROCEDURE WAS COMPLETED AS THE BIOPSIES THAT WERE PREVIOUSLY RETRIEVED WITH THIS DEVICE WERE SUFFICIENT. ADDITIONALLY, THE TECHNICIAN REPORTED THE FORCEPS DEVICE WAS TESTED PRIOR TO USE AND OPENED AND CLOSED CORRECTLY. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID¿ RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510880 13583465

    Patients

    Seq Age Sex Outcome Treatment
    1