MAUDE Adverse Event Report: ZEPHYR ENDOBRONCHIAL VALVE (EBV)

Model Number	ZEPHYR 4.0-J EDC
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, while sizing the lb6 airway with edc 4.0-j catheter, a sizing tab fell off the edc into the airway when the catheter was pulled into the bronchoscope.The sizing tab was removed from airway via bronchoscope suction.

• Brand Name: ZEPHYR ENDOBRONCHIAL VALVE (EBV)
• Common Device Name: ENDOBRONCHIAL VALVE
• MDR Report Key: 11773762
• Report Number: 3007797756-2021-00081
• Device Sequence Number: 19692340
• Product Code: NJK
• UDI-Device Identifier: 00811907030621
• UDI-Public: (01)00811907030621(10)505145V50(17)220813
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P180002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/13/2022
• Device Model Number: ZEPHYR 4.0-J EDC
• Device Catalogue Number: EDC-TS-4.0-J
• Device Lot Number: 505145-V5.0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 05/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2020
• 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
• Patient Age: 71 YR