BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPECT PULMONARY

    MDR report key: 8143873 · Received December 7, 2018

    Report

    Report Number
    3005099803-2018-61843
    Event Type
    Injury
    Date Received
    December 7, 2018
    Date of Event
    November 15, 2018
    Report Date
    January 11, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729861416
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK F10: DEVICE PROBLEM CODE 2944 CAPTURES THE REPORTABLE EVENT OF FOREIGN MATTER. BLOCK G5: 510K NUMBERS: K163248 & K151895. BLOCK H10: AN EXPECT PULMONARY NEEDLE DEVICE WAS RECEIVED FOR ANALYSIS. THE FOREIGN MATERIAL WAS NOT RETURNED. A VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THE WORKING LENGTH (NEEDLE AND SHEATH) WAS KINKED AT THE DISTAL END OF THE HANDLE AND THE DISTAL SECTION OF THE NEEDLE WAS ALSO BENT. THE NEEDLE WAS FULLY EXTENDED AND EXAMINED UNDER MAGNIFICATION AND WAS FOUND TO BE INTACT, WITH NO DAMAGE TO THE NEEDLE TIP AND SHEATH TIP OBSERVED. THE LENGTH OF THE NEEDLE AND SHEATH WERE MEASURED AND BOTH WERE WITHIN SPECIFICATIONS. A FUNCTIONAL EVALUATION WAS PERFORMED AND WHEN THE HANDLE WAS ACTUATED, THE NEEDLE COULD BE EXTENDED AND RETRACTED. BASED ON THE EVALUATION OF THE RETURNED DEVICE, THE WORKING LENGTH KINK MAY HAVE BEEN DUE TO EITHER HANDLING AND MANIPULATION OF THE DEVICE BY THE USER OR INTERACTION WITH THE SCOPE DURING THE PROCEDURE. THE FOREIGN MATERIAL WAS NOT RETURNED FOR ANALYSIS AND SINCE THE DEVICE DID NOT SHOW ANY EVIDENCE OF BROKEN PARTS, A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THEREFORE, THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS CAUSE NOT ESTABLISHED. 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 FOR DISTRIBUTION.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # PERTAINS TO THE FIRST EXPECT PULMONARY DEVICE AND MANUFACTURER REPORT # 3005099803-2018-61844 PERTAINS TO THE SECOND EXPECT PULMONARY DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO EXPECT PULMONARY TRANSBRONCHIAL ASPIRATION NEEDLES WERE USED WITH A SCOPE DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, AFTER USE OF THE NEEDLES IN THE PATIENT, THERE WAS A SMALL BLACK PIECE OF FOREIGN MATERIAL LEFT INSIDE THE PATIENT. THE FOREIGN MATERIAL WAS REMOVED USING FORCEPS. THE SCOPE AND BOTH NEEDLES WERE INSPECTED AND NEITHER APPEARED DAMAGED, AND IT WAS UNCLEAR WHICH DEVICE THE FOREIGN MATERIAL CAME FROM. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL TWO EXPECT PULMONARY NEEDLES. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. ADDITIONAL INFORMATION RECEIVED JANUARY 09, 2018. REPORTEDLY, THE COMPLAINANT BELIEVES THE FOREIGN MATERIAL MAY HAVE BEEN FROM THE SCOPE.

    Additional Manufacturer Narrative · 1

    (B)(4). 510K NUMBER: K163248 & K151895. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. THIS MANUFACTURER REPORT PERTAINS TO THE FIRST EXPECT PULMONARY DEVICE AND MANUFACTURER REPORT # 3005099803-2018-61844 PERTAINS TO THE SECOND EXPECT PULMONARY DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO EXPECT PULMONARY TRANSBRONCHIAL ASPIRATION NEEDLES WERE USED WITH A SCOPE DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, AFTER USE OF THE NEEDLES IN THE PATIENT, THERE WAS A SMALL BLACK PIECE OF FOREIGN MATERIAL LEFT INSIDE THE PATIENT. THE FOREIGN MATERIAL WAS REMOVED USING FORCEPS. THE SCOPE AND BOTH NEEDLES WERE INSPECTED AND NEITHER APPEARED DAMAGED, AND IT WAS UNCLEAR WHICH DEVICE THE FOREIGN MATERIAL CAME FROM. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL TWO EXPECT PULMONARY NEEDLES. 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
    980706 EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE EOQ BOSTON SCIENTIFIC CORPORATION M00558250 0022792308 08714729861416

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention