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

Model Number	ZEPHYR 5.5 DUAL MARK 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	11/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, the patient underwent a bronchoscopic lung volume reduction (blvr) procedure with zephyr valves.The physician used a zephyr 5.5 dual mark endobronchial delivery catheter which was inserted through the bronchoscope to size the airways, and then was removed to load a valve.Quickly after inserting the catheter a second time through the bronchoscope channel, it was noticed that one of the larger sizing wings was detached.The sizing wing was removed and was not left in the patient.

• Brand Name: ZEPHYR ENDOBRONCHIAL DELIVERY CATHETER
• Common Device Name: ENDOBRONCHIAL VALVE
• Manufacturer (Section D): PULMONX CORPORATION; 700 chesapeake drive; redwood city CA 94063
• Manufacturer Contact: mahtab fatemi ; 700 cheseapeake drive; redwood city, CA 94063 ; 6504072823
• MDR Report Key: 12933788
• Report Number: 3007797756-2021-00355
• Device Sequence Number: 20060006
• Product Code: NJK
• UDI-Device Identifier: 00811907031222
• UDI-Public: (01)00811907031222(10)505553V50(17)230426
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2021

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: 04/26/2023
• Device Model Number: ZEPHYR 5.5 DUAL MARK EDC
• Device Catalogue Number: EDC-TS-5.5-DM
• Device Lot Number: 505553-V5.0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2021
• 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 Sex: Unknown