BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPECT PULMONARY OLYMPUS 22GA - BOX 5

    MDR report key: 8219621 · Received January 4, 2019

    Report

    Report Number
    3005099803-2018-62444
    Event Type
    Injury
    Date Received
    January 4, 2019
    Date of Event
    December 11, 2018
    Report Date
    March 1, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729861430
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PREMARKET/510(K)#: K163248&K151895. PROBLEM CODE 2907 CAPTURES THE REPORTABLE EVENT OF NEEDLE BROKEN. INVESTIGATION RESULTS: AN EXPECT PULMONARY NEEDLE WAS RECEIVED. AN EXAMINATION OF THE DEVICE REVEALED THAT THE DISTAL END OF THE NEEDLE WAS FOUND BENT AND BROKEN. THE BROKEN SECTION OF THE DEVICE HAS MARKS AND IRREGULARITIES ON ITS SURFACE. NO OTHER ISSUE WAS NOTED. BASED ON THE EVALUATION OF THE RETURNED DEVICE, THE BROKEN SECTION OF THE DEVICE (DISTAL END OF THE NEEDLE) WAS FOUND BENT AND ALSO HAD MARKS AND IRREGULARITIES ON ITS SURFACE INDICATING EXCESS OF FORCE APPLIED TO THE UNIT DURING HANDLING OF THE PRODUCT. THEREFORE THE MOST PROBABLE ROOT CAUSE CLASSIFICATION FOR THIS EVENT IS ADVERSE EVENT RELATED TO PROCEDURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS AT THE TIME OF RELEASE OF DISTRIBUTION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE WAS USED IN STATION 7 DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE PART OF THE NEEDLE BROKE INSIDE THE PATIENT AND WAS RETRIEVED USING A BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH A 22A OLYMPUS VIZISHOT. 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.

    Additional Manufacturer Narrative · 1

    PREMARKET/510(K) #: K163248 & K151895. PROBLEM CODE CAPTURES THE REPORTABLE EVENT OF NEEDLE BROKEN. ALTHOUGH EXPECTED, 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 MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE WAS USED IN STATION 7 DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE PART OF THE NEEDLE BROKE INSIDE THE PATIENT AND WAS RETRIEVED USING A BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH A 22A OLYMPUS VIZISHOT. 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
    11623 EXPECT PULMONARY OLYMPUS 22GA - BOX 5 ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE EOQ BOSTON SCIENTIFIC CORPORATION M00558221 0021761221 08714729861430

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention