BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID¿ RX

    MDR report key: 2360872 · Received December 7, 2011

    Report

    Report Number
    3005099803-2011-04166
    Event Type
    Malfunction
    Date Received
    December 7, 2011
    Date of Event
    November 11, 2011
    Report Date
    November 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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).

    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 (SIDECAR) PRESENTED WITH PUSHBACK AND WAS TORN AT THE PROXIMAL END. FUNCTIONALLY, THE BASKET WAS EXTENDED AND RETRACTED MULTIPLE TIMES WITHOUT ISSUE (SOME RESISTANCE WAS FELT WHILE EXTENDING IT FOR THE FIRST TIME DUE TO THE HEAVY RESIDUE). WHEN EXTENDED, THE BASKET WIRES WERE EVENLY SPACED AND UNDEFORMED. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE BASKET WOULDN¿T CLOSE FULLY. THE EVALUATION CONFIRMED THE FULL EXTENSION AND RETRACTION OF THE BASKET. HOWEVER, THE GUIDEWIRE LUMEN (SIDECAR) PRESENTED WITH PUSHBACK AND WAS TORN. THE MOST PROBABLE ROOT CAUSE FOR THIS DAMAGE IS OPERATIONAL CONTEXT AS EXCESSIVE FORCE MAY HAVE BEEN APPLIED TO THE DEVICE DUE TO ANATOMICAL OR PROCEDURAL FACTORS. 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. (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), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE BASKET WOULD NOT RETRACT FULLY INTO THE SHEATH AFTER BEING OPENED INSIDE THE PATIENT FOR ONE PASS. THE DEVICE WAS REMOVED AND 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 AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE BASKET WOULD NOT RETRACT FULLY INTO THE SHEATH AFTER BEING OPENED INSIDE THE PATIENT FOR ONE PASS. THE DEVICE WAS REMOVED AND 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 LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510880 14400325

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR