BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID¿ RX

    MDR report key: 2973732 · Received February 22, 2013

    Report

    Report Number
    3005099803-2013-00896
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    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

    PATIENT AGE/DATE OF BIRTH IS UNKNOWN; HOWEVER, THE PATIENT WAS REPORTED AS BEING OVER 18 YEARS OLD. (B)(4). 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

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND RESIDUE ON THE DEVICE INDICATING PROCEDURAL USE AND THE BASKET WAS IN THE CLOSED POSITION WITH THE TIP INTACT. THE GUIDEWIRE LUMEN (SIDE-CAR) PRESENTED PUSH-BACK AND THE COIL ASSEMBLY WAS FOUND TO BE BUCKLED NEAR THE DISTAL END. THE GUIDEWIRE LUMEN WAS TORN AT BOTH THE PROXIMAL AND DISTAL ENDS. A FUNCTIONAL EVALUATION TO EXTEND THE BASKET WAS UNSUCCESSFUL DUE THE RESIDUE INSIDE THE DEVICE. THE BASKET WAS MANUALLY EXTENDED AND RETRACTED AND THE WIRES WERE FOUND TO BE EVEN SPACED AND NOT DEFORMED. THE BASKET WIRES WERE FOUND TO BE COVERED WITH HEAVY GREEN RESIDUE. 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. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE BASKET TIP FAILED TO DETACH. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS THE COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED. (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 BILE DUCT STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, AFTER USING THE BASKET DEVICE TO REMOVE SEVERAL STONES WITHOUT ISSUE FROM THE BILE DUCT, THE PHYSICIAN GRASPED AND CAPTURED THE FINAL STONE WITHIN THE BASKET. HOWEVER, THE 2CM STONE APPARENTLY BECAME JAMMED IN THE BASKET, AND AN ATTEMPT TO DISENGAGE THE BASKET'S DISTAL TIP WAS UNSUCCESSFUL. REPORTEDLY, AN ALLIANCE HANDLE WAS USED DURING THE PROCEDURE AND DID NOT MALFUNCTION. THE BASKET WITH THE ENCAPSULATED STONE WAS WITHDRAWN ALONG WITH THE ENDOSCOPE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET DEVICE. NO DEVICE DAMAGE WAS NOTED.. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING STABLE.

    Description of Event or Problem · 1

    IT WAS 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) 2013. ACCORDING TO THE COMPLAINANT, AFTER USING THE BASKET DEVICE TO REMOVE SEVERAL STONES WITHOUT ISSUE FROM THE BILE DUCT, THE PHYSICIAN GRASPED AND CAPTURED THE FINAL STONE WITHIN THE BASKET. HOWEVER, THE 2CM STONE APPARENTLY BECAME JAMMED IN THE BASKET, AND AN ATTEMPT TO DISENGAGE THE BASKET'S DISTAL TIP WAS UNSUCCESSFUL. REPORTEDLY, AN ALLIANCE HANDLE WAS USED DURING THE PROCEDURE AND DID NOT MALFUNCTION. THE BASKET WITH THE ENCAPSULATED STONE WAS WITHDRAWN ALONG WITH THE ENDOSCOPE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET DEVICE. NO DEVICE DAMAGE WAS NOTED.. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77737 TRAPEZOID¿ RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510890 15582486

    Patients

    Seq Age Sex Outcome Treatment
    1