BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2143323 · Received June 29, 2011

    Report

    Report Number
    3005099803-2011-02238
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 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

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND RESIDUE ON THE DEVICE INDICATING PROCEDURAL USE AND THE BASKET WAS IN THE OPEN POSITION. THE GUIDEWIRE LUMEN (SIDE-CAR) PRESENTED PUSH-BACK, AND ONE OF THE BASKET WIRES WAS FRAYED AND BROKEN. ADDITIONALLY, IT WAS NOTED THAT THE BASKET WIRES WERE FOUND TO BE CROSSED AS THE BASKET HAD BEEN FOLDED OVER OR INVERTED. FUNCTIONALLY THE BASKET WAS DIFFICULT TO EXTEND AND RETRACT DUE TO THE DAMAGE NOTED. A MICROSCOPIC ANALYSIS OF THE DAMAGED BASKET WIRE REVEALED THE FRACTURED WIRE ENDS APPEAR TO HAVE NECKED DOWN INDICATING THAT IT FAILED WHILE UNDERGOING SHEAR OR TENSILE FORCE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE 'ONE OF THE FOUR BASKET WIRES WAS FOUND TO BE UNRAVELED/FRAYED'. 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 SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. (B)(4).

    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).

    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 PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, WHILE PREPARING FOR THE PROCEDURE, ONE OF THE FOUR BASKET WIRES WAS FOUND TO BE UNRAVELED/FRAYED. ADDITIONALLY, THE BASKET TIP WAS KINKED/BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET DEVICE. 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.

    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 PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, WHILE PREPARING FOR THE PROCEDURE, ONE OF THE FOUR BASKET WIRES WAS FOUND TO BE UNRAVELED/FRAYED. ADDITIONALLY, THE BASKET TIP WAS KINKED/BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET DEVICE. 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.

    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 13837071

    Patients

    Seq Age Sex Outcome Treatment
    1