BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1935948 · Received December 22, 2010

    Report

    Report Number
    3005099803-2010-05274
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 25, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE ASSEMBLY CUT IN TWO AT THE DISTAL END OF THE HEAT SHRINK. THE BASKET WIRE ASSEMBLY HAD BEEN PULLED OUT OF THE COIL ASSEMBLY AND WAS TWISTED AND BENT. BASKET WIRES WERE UNEVENY SPACED AND DEFORMED. THE COIL ASSEMBLY WAS FOUND TO BE BUCKLED IN MULTIPLE AREAS, THE BASKET TIP SECURELY ATTACHED TO BASKET, AND THE GUIDEWIRE LUMEN (SIDE-CAR) PRESENTED PUSH-BACK. THE PROXIMAL ENDS OF THE PULL WIRE, OUTER CLEAR SHEATH AND COIL ASSEMBLY APPEAR TO HAVE BEEN CUT AND SHOW NO INDICATION OF BEING SHEARED WHILE IN TENSION. A MATERIAL REVIEW OF THE BROKEN COMPONENT FOUND NO ANOMALIES AND CONCLUDED THAT THE PULL-WIRE MET THE SPECIFICATIONS. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE TIP FAILED TO DETACH. 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. A LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6) - NO CODE AVAILABLE (INTERVENTION REQUIRED TO REMOVE THE DEVICE).(B)(4) THE REPORTED EVENT OF TIP WON'T DETACH.THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 LITHOTRIPTER COMPATABLE BASKET WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6) 2010. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE WHEN A STONE WAS ATTEMPTED TO BE CRUSHED, IT CAUSED THE SHEATH AND COIL NEAR THE HANDLE TO BREAK. THE TIP OF THE BASKET DID NOT DETACH. THEY WERE UNABLE TO REMOVE THE BASKET FROM THE PATIENT, AND A MECHANICAL WURBS LITHOTRIPTER WAS USED TO DESTROY THE STONE AND THEN, THE TRAPEZOID BASKET WAS REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENTS CONDITION HAS BEEN DESCRIBED AS "STABLE."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID LITHOTRIPTER COMPATABLE BASKET WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE WHEN A STONE WAS ATTEMPTED TO BE CRUSHED, IT CAUSED THE SHEATH AND COIL NEAR THE HANDLE TO BREAK. THE TIP OF THE BASKET DID NOT DETACH. THEY WERE UNABLE TO REMOVE THE BASKET FROM THE PATIENT, AND A MECHANICAL WURBS LITHOTRIPTER WAS USED TO DESTROY THE STONE AND THEN THE TRAPEZOID BASKET WAS REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENTS CONDITION HAS BEEN DESCRIBED AS "STABLE."

    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 0013604297

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention WURBS LITHOTRYPER