BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1884306 · Received October 27, 2010

    Report

    Report Number
    3005099803-2010-04496
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 5, 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

    (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 THE SIDE-CAR HAD EVIDENCE OF SLIGHT DEFORMATION AND PRESENTED SLIGHT PUSH-BACK. FUNCTIONALLY THE BASKET WOULD NOT EXTEND NORMALLY AND HAD TO BE FORCED OPEN DUE TO HEAVY RESIDUE CAUSING INTERFERENCE BETWEEN BASKET AND COIL ASSEMBLIES. THE BASKET WIDTH AND LENGTH WAS MEASURED AND WAS FOUND TO BE WITHIN SPECIFICATIONS. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT; INCORRECT PACKAGE CONTENTS. EVALUATION OF THE COMPLAINT DEVICE FOUND THAT IT MET ALL MANUFACTURING SPECIFICATIONS ACCORDING TO SIZE. THEREFORE, THE COMPLAINT IS NOT CONFIRMED. HOWEVER, DURING DEVICE EVALUATION IT WAS NOTED THAT THE SIDE-CAR HAD EVIDENCE OF SLIGHT DEFORMATION AND PRESENTED A SLIGHT PUSH-BACK. THE MOST PROBABLE ROOT CAUSE FOR THIS IS OPERATIONAL CONTEXT AS FORCE MAY HAVE BEEN APPLIED TO THE DEVICE DUE TO ANATOMICAL OR PROCEDURAL FACTORS. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING A COMMON BILE DUCT STONE REMOVAL PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PACKAGE WAS OPENED AND THE DEVICE TESTED, IT WAS NOTED THAT THE BASKET SIZE WAS "WRONG". REPORTEDLY THE DEVICE DID NOT MATCH THE PACKAGE LABELING, AS THE BASKET WAS SMALLER THAN INDICATED ON THE PACKAGING. FURTHERMORE, WHEN ASKED HOW THE DEVICE WAS MEASURED, IT WAS REPORTED THAT IT WAS VERIFIED VISUALLY ONLY. THE PROCEDURE WAS COMPLETED WITH THIS 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 USED DURING A COMMON BILE DUCT STONE REMOVAL PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PACKAGE WAS OPENED AND THE DEVICE TESTED, IT WAS NOTED THAT THE BASKET SIZE WAS "WRONG". REPORTEDLY THE DEVICE DID NOT MATCH THE PACKAGE LABELING, AS THE BASKET WAS SMALLER THAN INDICATED ON THE PACKAGING. FURTHERMORE, WHEN ASKED HOW THE DEVICE WAS MEASURED, IT WAS REPORTED THAT IT WAS VERIFIED VISUALLY ONLY. THE PROCEDURE WAS COMPLETED WITH THIS 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 0013619363

    Patients

    Seq Age Sex Outcome Treatment
    1