MAUDE Adverse Event Report: ZEPHYR ENDOBRONCHIAL DELIVERY CATHETER; ENDOBRONCHIAL VALVE

Model Number ZEPHYR 4.0-J EDC

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 06/15/2020

Event Type  malfunction  

Event Description

On (b)(6) 2020, the patient underwent a bronchoscopic lung volume reduction (blvr) procedure with zephyr valves.One of the sizing wings of the zephyr 4.0-j endobronchial delivery catheter (edc) detached during the procedure and was deposited into the patient's airway.The piece was promptly removed from the patient, and a different zephyr 4.0-j edc was opened and used for the remainder of the procedure.

Manufacturer Narrative

Device evaluation summary was inadvertently not attached in the initial report.This follow-up report includes the attachment with the device evaluation summary.

• Brand Name: ZEPHYR ENDOBRONCHIAL DELIVERY CATHETER
• Type of Device: ENDOBRONCHIAL VALVE
• MDR Report Key: 10273992
• MDR Text Key: 201218425
• Report Number: 3007797756-2020-00152
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030621
• UDI-Public: (01)00811907030621(10)504666V50(17)211217
• Combination Product (y/n): N
• PMA/PMN Number: P180002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2021
• Device Model Number: ZEPHYR 4.0-J EDC
• Device Catalogue Number: EDC-TS-4.0-J
• Device Lot Number: 504666-V5.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Date Manufacturer Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention