BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1850367 · Received October 1, 2010

    Report

    Report Number
    3005099803-2010-04107
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND RESIDUE ON THE DEVICE INDICATING USE. ADDITIONALLY IT WAS NOTED THAT THE COIL ASSEMBLY OUTER SHEATH WAS TORN AWAY FROM COIL, THE SIDE-CAR WAS TORN AND ALSO PRESENTED PUSH-BACK. A FUNCTIONAL EVALUATION OF THE DEVICE WAS PERFORMED BY EXTENDING AND RETRACTING THE BASKET WITHOUT ISSUE. BASKET WIRES WERE FOUND NOT FOUND TO BE FOLDED OVER BUT WERE EVENLY SPACED AND UNDEFORMED. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT; CATHETER SPILT. THE MOST PROBABLE ROOT CAUSE IS END USER HANDLING OF THE DEVICE, AS THE DAMAGE OBSERVED TO THE DEVICE MOST LIKELY OCCURRED DURING PREPARATION. 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).

    Additional Manufacturer Narrative · 1

    (B)(4):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)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS (TO BE) USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, WHILE TESTING THE BASKET OUTSIDE THE PATIENT, IT WAS NOTED THAT THERE WAS A SPLIT DOWN THE SIDE OF THE PLASTIC CATHETER. WHEN THEY ATTEMPTED TO OPEN THE BASKET, IT DID NOT COME OUT STRAIGHT BUT IT "FLOPPED" OUT TO THE SIDE. 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 (TO BE) USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, WHILE TESTING THE BASKET OUTSIDE THE PATIENT, IT WAS NOTED THAT THERE WAS A SPLIT DOWN THE SIDE OF THE PLASTIC CATHETER. WHEN THEY ATTEMPTED TO OPEN THE BASKET, IT DID NOT COME OUT STRAIGHT BUT IT "FLOPPED" OUT TO THE SIDE. 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 M00510880 13104159

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR