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

Model Number	ZEPHYR 4.0 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	01/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a bronchoscopic lung volume reduction procedure on (b)(6) 2023 with zephyr valves, one sizing wing on the zephyr 4.0 endobronchial delivery catheter (edc) came off after successful airway sizing and loading of valve.Bronchoscopic inspection did not lead to locating the alleged missing sizing wing.Suction evacuates to a wall mounted system so inspection of suctioned material was not possible.Another new edc was subsequently used, and the case proceeded with no further complications.

• 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 chesapeake drive; redwood city, CA 94063 ; 6504072823
• MDR Report Key: 16401026
• Report Number: 3007797756-2023-00023
• Device Sequence Number: 14879406
• Product Code: NJK
• UDI-Device Identifier: 00811907030522
• UDI-Public: (01)00811907030522(10)505957V50(17)231202
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2023

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: 12/02/2023
• Device Model Number: ZEPHYR 4.0 EDC
• Device Catalogue Number: EDC-TS-4.0
• Device Lot Number: 505957-V5.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• 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