MAUDE Adverse Event Report: AURIS HEALTH, INC. ASPIRATING BIOPSY NEEDLE; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Catalog Number MBR-000012

Device Problems Fracture (1260); Material Fragmentation (1261); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 04/03/2019

Event Type  malfunction  

Event Description

While attempting to acquire a 3rd sample with the aspirating biopsy needle, the distal portion of the needle separated.The needle fragment was approximately 3 cm long.Attempts to recover the needle fragment were unsuccessful; the needle was not retrieved from the patient.No complications or serious injuries to the patient were reported to have occurred as a result of this malfunction.Unrelated to the needle remaining in the patient due to the malfunction, the patient has undergone a lobectomy to address a presented malignancy.As a result, the needle is no longer in the patient.The root cause of this malfunction is under investigation.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

Manufacturer Narrative

Device evaluation: an evaluation was performed through trend analysis and testing of devices from other lots.The investigator was able to reproduce the needle failure and concluded that the needle kinked due to passing or articulating the needle through a damaged scope lumen.When passed through the damaged lumen after it became kinked, the needle broke off at the site of the kink.The use of the biopsy needle through a damaged scope lumen most likely caused the needle to kink and break.

• Brand Name: ASPIRATING BIOPSY NEEDLE
• Type of Device: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): AURIS HEALTH, INC.; 150 shoreline drive; redwood city CA 94065
• Manufacturer (Section G): AURIS HEALTH, INC.; 150 shoreline drive; redwood city CA 94065
• Manufacturer Contact: elizabeth osuna ; 150 shoreline drive; redwood city, CA 94065 ; 6504436730
• MDR Report Key: 8542642
• MDR Text Key: 143052583
• Report Number: 3014447948-2019-00005
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173760
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Relabeling
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2019
• Device Catalogue Number: MBR-000012
• Device Lot Number: 181210-3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3014447948-04/25/19-001C
• Patient Sequence Number: 1