BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1905098 · Received November 22, 2010

    Report

    Report Number
    3005099803-2010-04874
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 1, 2010
    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 IS UNKNOWN; HOWEVER REPORTED TO BE OVER 18 YEARS OLD. 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 THE DISTAL END OF THE SIDE-CAR TO BE COLLAPSED. THE SIDE-CAR WAS NOT FOUND TO BE TORN OR DAMAGED AND NO OTHER ISSUES WERE FOUND WITH THE DEVICE. FUNCTIONALLY A GUIDEWIRE COULD NOT BE INSERTED INTO THE DISTAL END OF THE SIDE-CAR DUE TO THE COLLAPSED END. THE LUMEN OPENED RIGHT UP AND REMAINED OPEN ONCE THE GUIDEWIRE WAS INSERTED INTO THE PROXIMAL END AND PASSED THROUGH. 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 NOT CONSISTENT WITH THE COMPLAINT THAT THE SIDE-CAR WAS TORN/CRUSHED/DAMAGED. HOWEVER IT WAS CONFIRMED THAT THE SIDE-CAR PRESENTED GUIDEWIRE PASSAGE RESTRICTION. THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE DUE TO THE LACK OF EVIDENCE IDENTIFYING THE USE OF THE DEVICE. THE INITIAL MDR REPORTED THAT THE SIDE-CAR CRUSHED/DAMAGED. HOWEVER, THE INVESTIGATION DID NOT CONFIRM THIS DAMAGE, THEREFORE, THIS IS NOT CONSIDERED A REPORTABLE EVENT. (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 AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GUIDE WIRE COULD NOT BE INSERTED INTO THE SIDE-CAR LUMEN. IT WAS FOUND THAT THE DISTAL END OF THE LUMEN WAS CRUSHED. NO STONES HAD BEEN CAPTURED/CRUSHED PRIOR TO THIS. REPORTEDLY THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE. 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 USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GUIDE WIRE COULD NOT BE INSERTED INTO THE SIDE-CAR LUMEN. IT WAS FOUND THAT THE DISTAL END OF THE LUMEN WAS CRUSHED. NO STONES HAD BEEN CAPTURED/CRUSHED PRIOR TO THIS. REPORTEDLY THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE. 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 0013602839

    Patients

    Seq Age Sex Outcome Treatment
    1