BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1850406 · Received October 1, 2010

    Report

    Report Number
    3005099803-2010-04106
    Event Type
    Injury
    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
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS UNKNOWN; HOWEVER, REPORTED TO BE OVER 18 YEARS OLD. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4) - NO CODE AVAILABLE (INTERVENTION REQUIRED TO RETRIEVE THE BASKET). (B)(4) - NO CODE AVAILABLE (BASKET). (B)(4) THE REPORTED EVENT OF BASKET BREAK. 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 THAT THE BASKET/WIRE ASSEMBLY WAS MISSING FROM THE DEVICE AND THE COIL ASSEMBLY WAS BUCKLED. SIDE-CAR PUSH-BACK WAS PRESENT AND THE OUTER SHEATH WAS PEELED NEAR THE PROXIMAL THE END OF THE SIDE-CAR. THE DEVICE WAS DISASSEMBLED AND IT WAS FOUND THAT THE PULL-WIRE WAS BROKEN NEAR THE HANDLE CANNULA AND MICROSCOPIC EXAMINATION DETERMINED THAT THE WIRE HAD SHEARED APART. A LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT SINCE THE PULL-WIRE WAS FOUND TO BE BROKEN NEAR THE PROXIMAL HANDLE CANNULA. UPON MICROSCOPIC REVIEW IT WAS DETERMINED THAT THE PULL WIRE MOST LIKELY HAD SHEARED APART. A MATERIAL REVIEW OF THE BROKEN COMPONENT FOUND NO ANOMALIES AND CONCLUDED THAT THE PULL WIRE MET THE SPECIFICATIONS. ADDITIONALLY IT WAS FOUND THAT SIDE-CAR PUSH-BACK WAS PRESENT AND THE OUTER SHEATH WAS PEELED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS EXCESSIVE FORCE WAS MOST LIKELY APPLIED TO THE DEVICE DUE TO ANATOMICAL OR PROCEDURAL FACTORS. (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) 2010. ACCORDING TO THE COMPLAINANT, DURING THE LITHOTRIPSY PROCEDURE, BASKET BROKE OFF AT THE END OF THE METAL SHAFT NOT AT THE TIP LEAVING THE BASKET IN THE PATIENT. THE BASKET AND THE STONE WERE THEN RETRIEVED WITH A MOTHER DAUGHTER SCOPE. 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), 2010. ACCORDING TO THE COMPLAINANT, DURING THE LITHOTRIPSY PROCEDURE, BASKET BROKE OFF AT THE END OF THE METAL SHAFT NOT AT THE TIP LEAVING THE BASKET IN THE PATIENT. THE BASKET AND THE STONE WERE THEN RETRIEVED WITH A MOTHER DAUGHTER SCOPE. 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 LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510860

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention