BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPECT PULMONARY

    MDR report key: 20605639 · Received November 4, 2024

    Report

    Report Number
    3005099803-2024-05553
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Date of Event
    June 15, 2024
    Report Date
    December 10, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729861409
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G5: PREMARKET/510(K) #: K163248 & K151895. BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF SHEATH DETACHED. BLOCK H11: INVESTIGATION RESULTS THE RETURNED EXPECT PULMONARY NEEDLE WAS RECEIVED FOR ANALYSIS. VISUAL EXAMINATION REVEALED THAT THE DEVICE'S SHEATH ADJUSTMENT KNOB WAS FOUND CROOKED. ALSO, THE WORKING LENGTH WAS FOUND BENT. NO ISSUES WERE NOTED ON THE SHEATH. THE REPORTED EVENT WAS NOT CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE DEVICE'S SHEATH ADJUSTMENT KNOB WAS FOUND CROOKED. THIS COULD HAVE HAPPENED AS RESULT OF TIGHTENING THE KNOB WITH TOO MUCH FORCE DURING THE PROCEDURE, MAKING THE KNOB EXCEED THE TIGHTENING LIMIT. ADDITIONALLY, THE WORKING LENGTH WAS FOUND BENT. IT IS POSSIBLE THAT THE KINK FOUND IN THE CATHETER OCCURRED DUE TO PROCEDURAL FACTORS SUCH AS EXCESS OF FORCE OR THE MANNER IN WHICH THE DEVICE WAS HANDLED AND MANIPULATED. EXCESSIVE MANIPULATION OF THE DEVICE WITHOUT ENOUGH CARE COULD HAVE INDUCED THE DEFECT FOUND. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATES THE MOST PROBABLE ROOT CAUSE IS NO PROBLEM DETECTED.

    Additional Manufacturer Narrative · 0

    BLOCK G5: PREMARKET/510(K) #: K163248 & K151895. BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF SHEATH DETACHED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED DURING A PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE SHEATH WAS DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER EXPECT PULMONARY NEEDLE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE DURING PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE SHEATH WAS DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER EXPECT PULMONARY NEEDLE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1625824 EXPECT PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00558220 0032544487 08714729861409

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown