BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACQUIRE PULMONARY

    MDR report key: 12417619 · Received September 2, 2021

    Report

    Report Number
    3005099803-2021-04401
    Event Type
    Injury
    Date Received
    September 2, 2021
    Date of Event
    August 6, 2021
    Report Date
    October 20, 2021
    Product Code
    EOQ
    UDI-DI
    08714729986225
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G4: PREMARKET / 510(K) #: K163248, K151895. BLOCK H6: MEDICAL DEVICE PROBLEM CODE A0501 CAPTURES THE REPORTABLE EVENT OF NEEDLE DETACHMENT. BLOCK H10: INVESTIGATION RESULTS: THE RETURNED ACQUIRE PULMONARY NEEDLE WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE NEEDLE WAS BENT AND BROKEN. THE WORKING LENGTH WAS KINKED AND THE BROKEN PART OF THE NEEDLE WAS NOT RETURNED. MEDIA INSPECTION WAS PERFORMED WITH TWO PICTURES PROVIDED BY THE CUSTOMER, ONE SHOWING THE DISTAL END OF THE NEEDLE WAS BROKEN OFF AND THE OTHER SHOWING THE ANATOMY. A FUNCTIONAL EVALUATION WAS PERFORMED, WHICH NOTED THAT THE NEEDLE COULD EXTENDED/RETRACTED WHEN THE HANDLE WAS ACTUATED AND THE STYLET COULD BE REMOVED AND REINSERTED WITHOUT PROBLEMS. LASTLY, A MICROSCOPE INSPECTION SHOWED THAT THE BROKEN END OF THE NEEDLE HAD AN IRREGULAR SHAPE/BENT. NO OTHER ISSUES WERE NOTED. THE REPORTED COMPLAINT WAS CONFIRMED. BASED ON ALL AVAILABLE INFORMATION AND THE CONDITION OF THE RETURNED DEVICE, THE NEEDLE WAS BENT BEFORE THE BREAK, WHICH COULD HAVE LEAD TO THE NEEDLE BREAKING OFF. THE BEND COULD HAVE BEEN CAUSED BY SOME TECHNIQUE APPLIED BY THE COSTUMER DURING THE PROCEDURE AND/OR SOME INTERACTION WITHIN ANOTHER DEVICE. THE OBSERVED KINKS THROUGH THE WORKING LENGTH MAY BE RELATED TO USER MANIPULATION, SOME TECHNIQUE APPLIED DURING PROCEDURE AND/OR SOME INTERACTION WITH ANOTHER DEVICE. THEREFOR THE INVESTIGATION CONCLUDED THE MOST PROBABLE CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. 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 ACQUIRE PULMONARY NEEDLE WAS USED ON A 4R LYMPH NODE DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE 4R LYMPH NODE WAS COMPLICATED TO REACH. THE FIRST PASS WITH THE ACQUIRE NEEDLE WAS SUCCESSFUL. THEN THE PHYSICIAN SWITCHED TO AN OLYMPUS 20GA NEEDLE SINCE HE THOUGHT IT WOULD BE EASIER FOR HIM, HOWEVER, HE STILL HAD DIFFICULTIES. THEY WENT BACK TO USING THE ACQUIRE NEEDLE WHICH WAS ALREADY BENT ON THE DISTAL PART OF THE NEEDLE. WHEN HE WANTED TO INSERT THE NEEDLE ON THE SHEATH, THE NEEDLE BROKE IN THE TRACHEA. THE BROKEN PIECE OF THE NEEDLE WAS RETRIEVED USING BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH THE OLYMPUS 20GA NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    PREMARKET / 510(K) #: K163248, K151895. (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER, THE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED ON A 4R LYMPH NODE DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE 4R LYMPH NODE WAS COMPLICATED TO REACH. THE FIRST PASS WITH THE ACQUIRE NEEDLE WAS SUCCESSFUL. THEN THE PHYSICIAN SWITCHED TO AN OLYMPUS 20GA NEEDLE SINCE HE THOUGHT IT WOULD BE EASIER FOR HIM, HOWEVER, HE STILL HAD DIFFICULTIES. THEY WENT BACK TO USING THE ACQUIRE NEEDLE WHICH WAS ALREADY BENT ON THE DISTAL PART OF THE NEEDLE. WHEN HE WANTED TO INSERT THE NEEDLE ON THE SHEATH, THE NEEDLE BROKE IN THE TRACHEA. THE BROKEN PIECE OF THE NEEDLE WAS RETRIEVED USING BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH THE OLYMPUS 20GA NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312435 ACQUIRE PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ M00552350 0027394760 08714729986225

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention