BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2063480 · Received April 19, 2011

    Report

    Report Number
    3005099803-2011-01344
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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 CLOSED POSITION. THE GUIDEWIRE LUMEN (SIDE-CAR) PRESENTED PUSH-BACK AND THE COIL WAS FOUND TO BE BUCKLED AND KINKED. THE DISTAL END OF THE DEVICE WAS FOUND TO BE CURVED AND THE HANDLE CANNULA HAD SLIGHT CURVING. FUNCTIONALLY THE BASKET EXTENDED BUT WITH RESISTANCE DUE TO THE RESIDUE AND THE OBSERVED DAMAGE. THE BASKET HAD BEEN INVERTED AND THE WIRES CROSSED, BENT AND UNEVEN. THE PROXIMAL BASKET BAND WAS ALSO FOUND TO BE EXPOSED. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT. THE BASKET WAS ABLE TO BE CLOSED AND NO COMPONENTS WERE FOUND TO BE BROKEN. HOWEVER DURING DEVICE EVALUATION IT WAS ALSO NOTED THAT THE GUIDEWIRE LUMEN (SIDE-CAR) PRESENTED PUSH-BACK AND THE COIL WAS KINKED AND BUCKLED. ADDITIONALLY, THE PROXIMAL BASKET BAND, WHICH IS NORMALLY SLIGHTLY WITHIN THE PROXIMAL END OF THE COIL ASSEMBLY, WAS FOUND TO BE EXPOSED. 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. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT ALL ACCEPTED DEVICES MET ALL MANUFACTURING SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4):THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 USED DURING A BILIARY STONE REMOVAL PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS ATTACHED TO AN ALLIANCE HANDLE TO CRUSH A STONE. AFTER CRUSHING THE STONE THE PHYSICIAN REMOVED THE DEVICE OUT OF THE PATIENT TO CLEAN AND INSPECT IT. THE BASKET WAS OPENED, FLUSHED, BUT WOULD NOT RE-CLOSE. UPON CLOSER INSPECTION THE PHYSICIAN NOTICED A METAL RING VISIBLE AT THE DISTAL END AND THE BASKET WOULD NOT MOVE. THE SIZE OF THE STONE CRUSHED WAS UNKNOWN. 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING A BILIARY STONE REMOVAL PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS ATTACHED TO AN ALLIANCE HANDLE TO CRUSH A STONE. AFTER CRUSHING THE STONE THE PHYSICIAN REMOVED THE DEVICE OUT OF THE PATIENT TO CLEAN AND INSPECT IT. THE BASKET WAS OPENED, FLUSHED, BUT WOULD NOT RE-CLOSE. UPON CLOSER INSPECTION THE PHYSICIAN NOTICED A METAL RING VISIBLE AT THE DISTAL END AND THE BASKET WOULD NOT MOVE. THE SIZE OF THE STONE CRUSHED WAS UNKNOWN. 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 FINE.

    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 14152316

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR