BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPECT PULMONARY OLYMPUS 22GA - BOX 5

    MDR report key: 16368740 · Received February 13, 2023

    Report

    Report Number
    3005099803-2023-00217
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    January 19, 2023
    Report Date
    April 20, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729861430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PREMARKET / 510(K) #: K163248, K151895. DEVICE CODE A180104 CAPTURES THE REPORTABLE EVENT OF A FILAMENT OF ABOUT 3MM CAME OUT OF THE NEEDLE.

    Additional Manufacturer Narrative · 0

    BLOCK G4: PREMARKET / 510(K) #: K163248, K151895. BLOCK H6: DEVICE CODE A180104 CAPTURES THE REPORTABLE EVENT OF A FILAMENT OF ABOUT 3MM CAME OUT OF THE NEEDLE. BLOCK H10: INVESTIGATION RESULTS ONE EXPECT PULMONARY NEEDLE WAS RECEIVED FOR ANALYSIS. MEDIA ANALYSIS OF THE RETURNED DEVICE FOUND NO SIGNS OF A POSSIBLE FOREIGN MATERIAL ON THE NEEDLE. THE REPORTED EVENT OF "DEVICE FOREIGN MATERIAL PRESENT IN DEVICE'' CANNOT BE CONFIRMED. THE POSSIBLE FOREIGN MATERIAL WAS NOT RETURNED AND IN ADDITION, NO SIGNS OR RESIDUES OF A POSSIBLE FOREIGN MATERIAL WERE FOUND. THE CONCLUSION IS ACCEPTABLE BECAUSE THE ANALYSIS OF THE AVAILABLE INFORMATION, PRODUCT ANALYSIS OF THE RETURNED DEVICE AND PRODUCT RECORD REVIEW DID NOT IDENTIFY ANY EVIDENCE OF EITHER THE ALLEGED ISSUE(S) OR ANY DEFECT ON THE DEVICE. ALSO, THE EVIDENCE FROM THE PRODUCT RECORD REVIEW DID NOT IDENTIFY A POTENTIAL PRODUCT QUALITY ISSUE OR NEW PATIENT HARM. THEREFORE, THE MOST PROBABLE CAUSE IS NO PROBLEM DETECTED. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE TRACHEOBRONCHIAL TREE DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PREPARATION, A FRAGMENT OF ABOUT 3MM WAS SEEN COMING OUT OF THE NEEDLE. REPORTEDLY, THE FRAGMENT FELL INTO THE PATIENT AND WAS ASPIRATED BY THE BRONCHOSCOPE. 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 IN THE TRACHEOBRONCHIAL TREE DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2023 DURING THE PROCEDURE, A FRAGMENT OF ABOUT 3MM WAS SEEN COMING OUT OF THE NEEDLE. REPORTEDLY, THE FRAGMENT FELL INTO THE PATIENT AND WAS ASPIRATED BY THE BRONCHOSCOPE. 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
    1654134 EXPECT PULMONARY OLYMPUS 22GA - BOX 5 BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00558221 0030421184 08714729861430

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown