BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1891300 · Received November 4, 2010

    Report

    Report Number
    3005099803-2010-04534
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 14, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND HEAVY ENCRUSTATION OF CONTRAST ON THE DISTAL END OF THE HEAT SHRINK. THE SIDE-CAR PRESENTED PUSH-BACK AND THE OUTER SHEATH WAS PULLED AWAY FROM DISTAL END OF THE HEAT SHRINK. FUNCTIONALLY, THE BASKET FAILED TO OPEN AND IT WAS FOUND THAT THE COIL MOVED FREELY IN THE HEAT SHRINK AS THE HANDLE WAS EXTENDED. THE BASKET WAS MANUALLY FORCED OPEN AND THE BASKET WIRES CONTAINED HEAVY CONTRAST RESIDUE. DISASSEMBLY OF THE UNIT REVEALED THAT IT WAS ASSEMBLED CORRECTLY. THE CONDITION OF THE RETURNED COMPLAINT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE BASKET WON'T OPEN. IT WAS FOUND THAT THE COIL MOVED FREELY IN THE HEAT SHRINK AS THE HANDLE WAS EXTENDED, AND THE BASKET DID NOT EXTEND. THE MOST PROBABLE ROOT CAUSE FOR THIS IS CONSIDERED OPERATIONAL CONTEXT AS HEAVY CONTRAST RESIDUE MOST LIKELY CAUSED INTERFERENCE BETWEEN THE BASKET ASSEMBLY AND THE COIL ASSEMBLY AND PREVENTED SMOOTH EXTENSION OF THE BASKET. FURTHERMORE, DURING DEVICE EVALUATION IT WAS FOUND THAT THE SIDE-CAR PRESENTED PUSH-BACK AND THE OUTER SHEATH WAS PULLED AWAY FROM DISTAL END OF THE HEAT SHRINK. THE MOST PROBABLE ROOT CAUSE FOR THIS IS OPERATIONAL CONTEXT AS EXCESSIVE FORCE WAS APPLIED TO THE DEVICE DUE TO ANATOMICAL OR PROCEDURAL FACTORS LIMITING THE DEVICE PERFORMANCE. 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 A BILE DUCT STONE REMOVAL PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS USED SUCCESSFULLY APPROXIMATELY TEN TIMES TO CRUSH/REMOVE STONES FROM THE BILE DUCT. AFTERWARDS, THE BASKET WAS NOT ABLE TO OPEN AND UPON INSPECTION IT WAS NOTED THAT THE SHEATH WAS DEFORMED, HOWEVER DETAILS WERE UNKNOWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET DEVICE. REPORTEDLY THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. 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; SIDE-CAR PUSH-BACK.

    Description of Event or Problem · 1

    IT WAS INITIALLY 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), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS USED SUCCESSFULLY APPROXIMATELY TEN TIMES TO CRUSH/REMOVE STONES FROM THE BILE DUCT. AFTERWARDS, THE BASKET WAS NOT ABLE TO OPEN AND UPON INSPECTION IT WAS NOTED THAT THE SHEATH WAS DEFORMED, HOWEVER DETAILS WERE UNKNOWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET DEVICE. REPORTEDLY THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. 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; SIDE-CAR PUSH-BACK.

    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 0013622370

    Patients

    Seq Age Sex Outcome Treatment
    1