BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPECT PULMONARY

    MDR report key: 15520384 · Received September 30, 2022

    Report

    Report Number
    3005099803-2022-05269
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    August 19, 2022
    Report Date
    November 23, 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

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

    Additional Manufacturer Narrative · 0

    BLOCK G4: PREMARKET / 510(K) #: K163248 & K151895. BLOCK H6: DEVICE CODE A180104 IS BEING USED TO CAPTURE THE REPORTABLE ISSUE OF DEVICE FOREIGN MATERIAL. BLOCK H10: INVESTIGATION RESULTS: THE RETURNED EXPECT PULMONARY NEEDLE WAS ANALYZED. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH WAS KINKED, AND ONE KNOB OF THE HANDLE WAS DETACHED AND DIDN'T RETURN FOR ANALYSIS. FUNCTIONAL INSPECTION WAS PERFORMED, AND THE DEVICE WAS FLUSHED, AND NO PROCEDURAL TRACES WERE FOUND. THE CUSTOMER PROVIDED A PHOTO WHERE BLACK RESIDUE IS OBSERVED; HOWEVER, THE RESIDUE DID NOT RETURN FOR ANALYSIS. IT IS NOT POSSIBLE TO CONFIRM THE MATERIAL PROPERTIES. NO OTHER PROBLEMS WERE NOTED. BASED ON ALL AVAILABLE INFORMATION AND THE CONDITION OF THE RETURNED DEVICE, IT IS POSSIBLE THAT FACTORS AND/OR CONDITIONS RELATED TO THE PROCEDURE DURING THE USE OF THE DEVICE COULD HAVE AFFECTED ITS PERFORMANCE AND ITS INTENDED PURPOSE, LEADING TO THE REPORTED EVENT. IN ADDITION, SINCE THE BLACK RESIDUE DID NOT RETURN FOR ANALYSIS, IT IS NOT POSSIBLE TO CONFIRM THE MATERIAL PROPERTIES. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS CAUSE NOT ESTABLISHED SINCE THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, A SMALL BLACK PIECE WAS PRESENT. IT IS BELIEVED TO BE FROM THE SHEATH CATHETER. 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 A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, A SMALL BLACK PIECE WAS PRESENT. IT IS BELIEVED TO BE FROM THE SHEATH CATHETER. 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
    2170470 EXPECT PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00558220 0029807997 08714729861409

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown