BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1839194 · Received September 20, 2010

    Report

    Report Number
    3005099803-2010-03984
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Report Date
    August 31, 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

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE SIDE-CAR PRESENTED PUSH-BACK, AND HEAVY RESIDUE BETWEEN OUTER SHEATH AND INNER COIL ASSEMBLY. FUNCTIONALLY THE BASKET WAS NOT ABLE TO BE OPENED WHEN APPLYING NORMAL FORCE TO THE HANDLE. AFTER MANUALLY FORCING THE BASKET TO OPEN, HEAVY RESIDUE WAS FOUND ON THE BASKET, AND THE BASKET WIRES WERE FOUND TO BE EVENLY SPACED AND NOT DEFORMED. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT; SIDE-CAR PUSH-BACK. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS EXCESSIVE FORCE WAS MOST LIKELY APPLIED TO THE DEVICE DURING USE DUE TO ANATOMICAL OR PROCEDURAL FACTORS. FURTHERMORE, DURING FUNCTIONAL ANALYSIS, IT WAS NOTED THAT THE BASKET WAS NOT ABLE TO BE OPENED WHEN APPLYING NORMAL FORCE DUE TO HEAVY RESIDUE CAUSING AN INTERFERENCE FIT BETWEEN THE BASKET AND COIL ASSEMBLIES. (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN.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 USED DURING AN EST PROCEDURE WITHIN THE PATIENT'S BILE DUCT.ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, RESISTANCE WAS FELT AT THE HANDLE AND THE BASKET DID NOT OPEN FULLY PRIOR TO CAPTURING A STONE. ADDITIONALLY, IT WAS REPORTED THAT THE CLEAR OUTER SHEATH WAS PUSHED BACK ABOUT 5MM FROM THE DISTAL END OF THE COIL SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER TYPE OF 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 EST PROCEDURE WITHIN THE PATIENT'S BILE DUCT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, RESISTANCE WAS FELT AT THE HANDLE AND THE BASKET DID NOT OPEN FULLY PRIOR TO CAPTURING A STONE. ADDITIONALLY, IT WAS REPORTED THAT THE CLEAR OUTER SHEATH WAS PUSHED BACK ABOUT 5MM FROM THE DISTAL END OF THE COIL SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER TYPE OF 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

    Patients

    Seq Age Sex Outcome Treatment
    1