BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1883239 · Received October 26, 2010

    Report

    Report Number
    3005099803-2010-04468
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS 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.(B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: VISUAL EVALUATION OF THE COMPLAINT DEVICE FOUND THE PROXIMAL PORTION OF THE SHEATH WAS BUCKLED AND WAS FOUND TO BE TWISTED 180 DEGREES. THE SIDE-CAR PRESENTED PUSH-BACK AND THE SHEATH/COIL ASSEMBLY WAS BUCKLED NEAR THE DISTAL END OF THE DEVICE. RESIDUE WAS VISIBLE BETWEEN THE OUTER SHEATH AND COIL AT DISTAL END OF THE COIL ASSEMBLY. AFTER EXTENDING THE BASKET DURING FUNCTIONAL EVALUATION, HEAVY RESIDUE WAS FOUND ON BASKET AND THE BASKET WIRES WERE BENT AND DEFORMED. THE DEVICE WAS DISASSEMBLED AND IT WAS DETERMINED THAT IT WAS PROPERLY ASSEMBLED. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT REPORT SINCE THE SHEATH WAS FOUND DAMAGED. DURING THE EVALUATION IT WAS NOTED THAT THE SHEATH WAS BUCKLED AND TWISTED BUT NO TEARS OR SPLITS WERE FOUND, ADDITIONALLY, THE BASKET WIRES WERE SEVERELY BENT AND OUT OF AXIS, WHILE HEAVY RESIDUE WAS ON THE BASKET AND THE SHEATH WAS BUCKLED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS EXCESSIVE FORCE MAY HAVE BEEN APPLIED TO THE DEVICE DUE TO ANATOMICAL OR PROCEDURAL FACTORS LIMITING THE DEVICE PERFORMANCE. 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 REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS TO BE USED DURING A STONE REMOVAL PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, FOR THE PROCEDURE, IT WAS NOTICED THAT THE DEVICE SHEATH WAS BROKEN. SINCE ANOTHER TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET OF SAME SIZE WAS NOT AVAILABLE A SMALLER SIZE TRAPEZOID RX LITHOTRIPTER BASKET WAS USED AND THE SMALLER STONES WERE SUCCESSFULLY CRUSHED/REMOVED. REPORTEDLY, LARGER STONES WERE NOT CRUSHED AT THIS TIME. 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS TO BE USED DURING A STONE REMOVAL PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, FOR THE PROCEDURE, IT WAS NOTICED THAT THE DEVICE SHEATH WAS BROKEN. SINCE ANOTHER TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET OF SAME SIZE WAS NOT AVAILABLE A SMALLER SIZE TRAPEZOID RX LITHOTRIPTER BASKET WAS USED AND THE SMALLER STONES WERE SUCCESSFULLY CRUSHED/REMOVED. REPORTEDLY, LARGER STONES WERE NOT CRUSHED AT THIS TIME. 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 STABLE.

    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 13646545

    Patients

    Seq Age Sex Outcome Treatment
    1