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

Catalog Number MBR-000012

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/24/2019

Event Type  malfunction  

Event Description

It was reported that after the physician's sixth pass with the subject device, the physician removed the needle to extract the samples and discovered that the needle had broken.The hospital staff used fluoroscopy and confirmed the needle had detached inside the patient and was within the lesion.No information has been provided on whether attempts were made to remove the needle, and there were no reported clinical consequences to the patient.

Manufacturer Narrative

Additional information: on (b)(6) 2019, the physician reported that the patient involved in this event was in good condition and discharged after a lobectomy procedure.The lobectomy procedure was in response to the patients disease: lung cancer.Coincidentally, the needle fragment was removed.A copy of user facility report # (b)(4) was also received in july 2019.Device evaluation: an evaluation was performed through trend analysis, analysis of production records, and testing of the subject device.The investigator was able to confirm the reported issue.The root cause for the device failure is manufacturing lot to lot variance due to an inadequate design specification.

• Brand Name: ASPIRATING BIOPSY NEEDLE
• Type of Device: BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES
• Manufacturer (Section D): AURIS HEALTH, INC.; 150 shorelien drive; redwood city CA 94065
• MDR Report Key: 8725642
• MDR Text Key: 188867519
• Report Number: 3014447948-2019-00011
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• PMA/PMN Number: K173760
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MBR-000012
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3014447948-04/25/19-001C
• Patient Sequence Number: 1