BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPECT PULMONARY

    MDR report key: 15508929 · Received September 29, 2022

    Report

    Report Number
    3005099803-2022-05490
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    September 19, 2022
    Report Date
    November 18, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729861409
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G4: PREMARKET / 510(K) #: K163248 & K151895. BLOCK H6: DEVICE CODE A180104 CAPTURES THE REPORTABLE EVENT OF FOREIGN MATERIAL. BLOCK H10: INVESTIGATION RESULTS THE RETURNED EXPECT PULMONARY NEEDLE WAS ANALYZED, AND A VISUAL INSPECTION OF THE RETURNED DEVICE NOTED THAT NO DAMAGES OR DEFECTS WERE FOUND. A FUNCTIONAL EVALUATION NOTED THAT THE HANDLE WAS ACTUATED, AND THE NEEDLE EXTENDED/RETRACTED SMOOTHLY. THE DEVICE WAS FLUSHED, AND NO WASTE WAS FOUND. NO FOREIGN MATERIAL WAS RETURNED WITH THE DEVICE. THE CUSTOMER PROVIDED ONE PHOTO; HOWEVER, IT WAS NOT POSSIBLE TO DETERMINE IN THE PHOTO IF THERE WAS FOREIGN MATERIAL. BASED ON THE AVAILABLE INFORMATION, IT IS POSSIBLE THAT THE MANIPULATION, OR EQUIPMENT USED COULD HAVE AFFECTED THE PROCEDURE CAUSING THE REPORTED COMPLAINT. HOWEVER, THERE IS NO EVIDENCE TO DETERMINE WHETHER THE PROBLEM WAS DUE TO SOME ISSUE IN THE DEVICE. NO SIGNS OR REMNANTS OF FOREIGN MATERIAL WERE FOUND INSIDE THE DEVICE. THEREFORE, BASED ON ALL GATHERED INFORMATION, THE COMPLAINT INVESTIGATION CONCLUSION CODE SELECTED IS NO PROBLEM DETECTED SINCE THERE IS NOT ENOUGH EVIDENCE TO CONFIRM THE REPORTED ISSUE. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Additional Manufacturer Narrative · 0

    PREMARKET / 510(K) #: K163248 & K151895. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, A SMALL BLACK FLAKE WAS SEEN IN THE LUNG AT THE SECOND OR THIRD PUNCTURE. THE PHYSICIAN ATTEMPTED TO ASPIRATE, BUT IT WAS NO LONGER VISIBLE IN THE LUNG AT THE END OF THE PROCEDURE. DURING THE FOURTH PUNCTURE WITH THE SAME NEEDLE, THE NEEDLE WOULD NOT EXTEND. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPECT PULMONARY NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, A SMALL BLACK FLAKE WAS SEEN IN THE LUNG AT THE SECOND OR THIRD PUNCTURE. THE PHYSICIAN ATTEMPTED TO ASPIRATE, BUT IT WAS NO LONGER VISIBLE IN THE LUNG AT THE END OF THE PROCEDURE. DURING THE FOURTH PUNCTURE WITH THE SAME NEEDLE, THE NEEDLE WOULD NOT EXTEND. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPECT PULMONARY NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584117 EXPECT PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00558220 0029807997 08714729861409

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown