MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC. ALWAYS-ON TIP TRACKED 22GA ANSO SPIN FLEX NEEDLE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number INS-5410

Device Problem Output Problem (3005)

Patient Problems Hemorrhage/Bleeding (1888); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/16/2021

Event Type  Injury  

Event Description

A (b)(6) female patient undergoing a flexible bronchoscopy, endobronchial ultrasound, electromagnetic navigation, transbronchial needle aspirations, left upper lobe mass transbronchial lung biopsy, bronchoalveolar lavage.Once the patient was under general anesthesia the flexible bronchoscope was advanced through an lma and to the level of the larynx.The vocal cords were well visualized and moved symmetrically to the midline.A full airway survey was performed to the subsegmental levels, there were no endobronchial lesions, excessive secretions or masses, the patient had normal airway anatomy.Next we proceeded to do an endobronchial ultrasound, all mediastinal lymph node stations were assessed for enlarged lymph nodes, only tiny lymph nodes were visualized, the left hilar station 11 l lymph nodes were also assessed, again quite small.Since it is section of mediastinal lymph nodes by ebus was unremarkable, we proceeded to do electromagnetic navigation to guide into the left upper lobe mass.Unfortunately, there was no airway leading straight into the mass and multiple imaging it appeared we were side-by-side.We did do several transbronchial needle aspirations with the ed very needle and also awaiting needle.Onsite pathology was consistent with potential diagnostic sample, for this reason we continued to do tb na.We did a single transbronchial biopsy which is probably low yield.We did bal with 3 sequential aliquots of 50 mils normal saline.There was very minimal bleeding,.The procedure was very well tolerated.Fda safety report id# (b)(4).

• Brand Name: ALWAYS-ON TIP TRACKED 22GA ANSO SPIN FLEX NEEDLE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC.
• MDR Report Key: 12616028
• MDR Text Key: 276348569
• Report Number: MW5104539
• Device Sequence Number: 1
• Product Code: JAK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INS-5410
• Device Catalogue Number: INS-5410
• Device Lot Number: 04593200625
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR