BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1936004 · Received December 22, 2010

    Report

    Report Number
    3005099803-2010-05275
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    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)

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND RESIDUE ON THE DEVICE INDICATING PROCEDURAL USE AND THE BASKET WAS IN THE CLOSED POSITION. THE GUIDEWIRE LUMEN (SIDE-CAR) WAS TORN ALONG THE ENTIRE LENGTH. A FUNCTIONAL EVALUATION OF THE DEVICE WAS PERFORMED BY EXTENDING AND RETRACTING THE BASKET WITH NO ISSUES. THE BASKET WIRES WERE FOUND TO BE EVEN AND NOT DEFORMED. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE GUIDEWIRE LUMEN (SIDE-CAR) WAS TORN. 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 DAMAGE. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-05172, 3005099803-2010-05275 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT SYSTEM AND A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WERE USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6), 2010 DURING THE PROCEDURE, THE PROXIMAL END OF THE GUIDE CATHETER OF THE FLEXIMA BILIARY STENT SYSTEM BROKE, HOWEVER THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT AT THE TARGET SITE. THE DISTAL END OF THE GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ALLOWING THE DEVICE TO BE REMOVED IN ONE PIECE. NO FRAGMENTS OF THE BILIARY STENT SYSTEM DEVICE FELL INTO THE PATIENT. THE PHYSICIAN WAS ALSO UNABLE TO INSERT THE TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET ON THE GUIDEWIRE AS THE LATERAL CHANNEL (SIDE-CAR) OF THE BASKET WAS OPEN. REPORTEDLY THE TRAPEZOID LITHOTRIPTER BASKET WAS INSPECTED/TESTED PRIOR TO USE, AND NO STONES HAD BEEN CAPTURED AND/OR CRUSHED PRIOR TO THE ALLEGED FAILURE. 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 FINE AND STABLE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-05172, 3005099803-2010-05275 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT SYSTEM AND A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WERE USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2010. DURING THE PROCEDURE, THE PROXIMAL END OF THE GUIDE CATHETER OF THE FLEXIMA BILIARY STENT SYSTEM BROKE, HOWEVER THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT AT THE TARGET SITE. THE DISTAL END OF THE GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ALLOWING THE DEVICE TO BE REMOVED IN ONE PIECE. NO FRAGMENTS OF THE BILIARY STENT SYSTEM DEVICE FELL INTO THE PATIENT. THE PHYSICIAN WAS ALSO UNABLE TO INSERT THE TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET ON THE GUIDEWIRE AS THE LATERAL CHANNEL (SIDE-CAR) OF THE BASKET WAS OPEN. REPORTEDLY THE TRAPEZOID LITHOTRIPTER BASKET WAS INSPECTED/TESTED PRIOR TO USE, AND NO STONES HAD BEEN CAPTURED AND/OR CRUSHED PRIOR TO THE ALLEGED FAILURE. 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 FINE AND 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 M00510860 0013518223

    Patients

    Seq Age Sex Outcome Treatment
    1