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

Model Number	ZEPHYR 4.0-J EDC
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: ENDOBRONCHIAL VALVE
• MDR Report Key: 10273992
• Report Number: 3007797756-2020-00152
• Device Sequence Number: 16346661
• Product Code: NJK
• UDI-Device Identifier: 00811907030621
• UDI-Public: (01)00811907030621(10)504666V50(17)211217
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 07/14/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention