BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID? RX

    MDR report key: 3843071 · Received June 2, 2014

    Report

    Report Number
    3005099803-2014-02174
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 6, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. REPORTED EVENT OF TIP DETACHMENT. 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 MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE TIP OF THE BASKET WAS DETACHED AND NOT RETURNED. THE BASKET WIRES WERE RETRACTED INTO THE DISTAL END OF THE COIL ASSEMBLY. THE PROXIMAL END OF THE SIDE CAR-RX WAS TORN AND THE SIDE CAR-RX PRESENTED PUSHBACK. UPON EVALUATION, THE BASKET WIRES WERE EXTENDED AND FOUND TO BE PROPERLY FORMED. THE WIRES WERE COVERED WITH A STICKY RESIDUE. AN EXAMINATION OF THE WIRE ENDS FOUND THAT THE TIP HAD BEEN PREVIOUSLY ATTACHED AND THE WIRE ENDS DID NOT PRESENT ANY ISSUES. THE EVALUATION CONCLUDED THAT THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE TIP DETACHED. THE TIP WAS DETACHED AND THE BASKET WIRES WERE RETRACTED INTO THE COIL ASSEMBLY. THE DEVICE IS DESIGNED SO THAT THE BASKET TIP DETACHES IF THE STONE CANNOT BE CRUSHED. IT IS UNKNOWN IF THE BASKET TIP RECEIVED FORCE GREATER THAN 50 LB PRIOR TO TIP DETACHMENT. BECAUSE THE CUSTOMER DAMAGED THE DEVICE DURING PREPARATION AND OUTSIDE THE PATIENT, THEREFORE THE MOST PROBABLE ROOT CAUSE IS ''HANDLING DAMAGE''. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATABLE BASKET WAS OPENED DURING A PLANNED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE DUODENUM PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE NURSE INSPECTED THE DEVICE OUTSIDE THE PATIENT BY OPENING AND CLOSING THE BASKET USING AN ALLIANCE II HANDLE. THE HANDLE WAS SQUEEZED TOO TIGHT THAT THE TIP DETACHED UNINTENTIONALLY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 ¿STABLE."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATABLE BASKET WAS OPENED DURING A PLANNED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE DUODENUM PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE NURSE INSPECTED THE DEVICE OUTSIDE THE PATIENT BY OPENING AND CLOSING THE BASKET USING AN ALLIANCE II HANDLE. THE HANDLE WAS SQUEEZED TOO TIGHT THAT THE TIP DETACHED UNINTENTIONALLY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 ¿STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322439 TRAPEZOID? RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510890 0016581032

    Patients

    Seq Age Sex Outcome Treatment
    1