BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELON?

    MDR report key: 3221110 · Received July 11, 2013

    Report

    Report Number
    3005099803-2013-06496
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    June 17, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    EOQ
    PMA / PMN Number
    K040018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE BY REPORTER IS (B)(6) 2013, NO SPECIFIC DATE WAS GIVEN. (B)(4) FOR THE REPORTED EVENT OF THE NEEDLE PUNCTURING THROUGH THE SHEATH. THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL ASSESSMENT WAS PERFORMED. THE NEEDLE WAS RETRACTED WITH THE HANDLE IN THE RETRACTED POSITION WHEN RECEIVED. SHEATH WAS NOT PUNCTURED. NO KINKS WERE IDENTIFIED ON THE WORKING LENGTH. A FUNCTIONAL EVALUATION WAS PERFORMED. WHEN THE HANDLE WAS ACTUATED, THE NEEDLE WOULD NOT EXTEND; THE DISTAL END OF THE NEEDLE WAS STUCK ON THE PROXIMAL SIDE OF THE DISTAL STOP. THE DISTAL END OF THE SHEATH WAS PULLED STRAIGHT, AND THE NEEDLE WAS PLACED BACK IN POSITION. THEN, THE HANDLE WAS ACTUATED, AND THE NEEDLE WOULD EXTEND AND RETRACT WITHOUT ISSUE. BASED ON EVALUATION RESULTS WHICH REVEALED THAT THE SHEATH WAS NOT PUNCTURED; THIS EVENT IS NO LONGER CONSIDERED MDR REPORTABLE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION.  A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. SINCE THE SHEATH WAS NOT PUNCTURED, THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED EVENT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELONTRANSBRONCHIAL ASPIRATION NEEDLE DEVICE WAS USED DURING A TRANSBRONCHIAL BIOPSY NEEDLE ASPIRATION PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE INSIDE THE PATIENT¿S LUNG, THE EXCELONTRANSBRONCHIAL ASPIRATION NEEDLE HAD DIFFICULTY RETRACTING AND PUNCTURED THOUGH THE SHEATH. REPORTEDLY, THERE WAS NO DAMAGE TO THE DEVICE PACKAGING AND WORKED WELL WHEN TESTED PRIOR TO USE. THERE WERE NO OTHER REPORTED ISSUES ENCOUNTERED WITH THIS DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE,THERE WAS NOTHING RELATED TO THE DEVICE HAD ANY IMPACT ON THE PATIENT CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELONTRANSBRONCHIAL ASPIRATION NEEDLE DEVICE WAS USED DURING A TRANSBRONCHIAL BIOPSY NEEDLE ASPIRATION PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE INSIDE THE PATIENT'S LUNG, THE EXCELONTRANSBRONCHIAL ASPIRATION NEEDLE HAD DIFFICULTY RETRACTING AND PUNCTURED THOUGH THE SHEATH. REPORTEDLY, THERE WAS NO DAMAGE TO THE DEVICE PACKAGING AND WORKED WELL WHEN TESTED PRIOR TO USE. THERE WERE NO OTHER REPORTED ISSUES ENCOUNTERED WITH THIS DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE,THERE WAS NOTHING RELATED TO THE DEVICE HAD ANY IMPACT ON THE PATIENT CONDITION. THIS EVENT HAS BEEN DEEMED A NON-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS SHEATH WAS NOT PUNCTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319870 EXCELON? BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC - SPENCER M00564121 15081259

    Patients

    Seq Age Sex Outcome Treatment
    1