BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2001105 · Received February 24, 2011

    Report

    Report Number
    3005099803-2011-00371
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    December 7, 2010
    Report Date
    February 3, 2011
    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 (B)(6). (B)(4), (SIDE-CAR PUSH-BACK). 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 WAS SPLIT AT THE PROXIMAL END. THE PROXIMAL END OF THE SHEATH WAS PULLED AWAY FROM THE HEAT SHRINK AND WAS BUCKLED. FUNCTIONALLY THE BASKET FAILED TO EXTEND DUE TO THE DAMAGE NOTED TO THE SHEATH BY ALLOWING THE COIL ASSEMBLY TO MOVE FREELY AND SLIDE DISTALLY WHEN AN ATTEMPT IS MADE TO EXTEND THE BASKET. THE BASKET WAS MANUALLY EXTENDED AND RETRACTED AND THE WIRES WERE FOUND TO BE EVEN SPACED AND NOT DEFORMED. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE BASKET WON'T OPEN. HOWEVER DURING DEVICE EVALUATION IT WAS ALSO NOTED THAT THE GUIDEWIRE LUMEN (SIDE-CAR) PRESENTED PUSH-BACK AND WAS SPLIT. ADDITIONALLY IT WAS NOTED THAT THE SHEATH WAS TORN AND BUCKLED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS EXCESSIVE FORCE MAY HAVE BEEN APPLIED TO THE DEVICE DUE TO ANATOMICAL OR PROCEDURAL FACTORS CAUSING THE OBSERVED DAMAGES. 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 INITIALLY REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING BILE DUCT STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE PRESENTED NO ISSUES DURING THE PREPARATION AND THE BASKET COULD OPEN AND CLOSE FINE WHILE OUTSIDE THE PATIENT. THE DEVICE WAS INSERTED INTO THE PATIENT, HOWEVER THE BASKET WOULD NOT OPEN. THE DEVICE WAS THEN REMOVED FROM THE PATIENT, TESTED, AND IT WAS CONFIRMED THAT THE BASKET COULD OPEN AND CLOSE. SINCE THE DEVICE FUNCTIONED PROPERLY, IT WAS REINSERTED INTO THE PATIENT, BUT THE BASKET COULD NOT OPEN FULLY AT EITHER THE LOWER BILE DUCT AND UPPER BILE DUCT. THE PROCEDURE WAS COMPLETED WITH A RETRIEVAL BALLOON AND A 7FR EBD TUBE. REPORTEDLY THE TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET DEVICE WAS TESTED AGAIN AFTER THE PROCEDURE OUTSIDE THE PATIENT, AND THE BASKET COULD OPEN. IT WAS REPORTED THAT NO DAMAGE WAS NOTED ON THE 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; SHEATH TORN, SIDE-CAR PUSH-BACK AND TORN.

    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 M00510870 13786994

    Patients

    Seq Age Sex Outcome Treatment
    1