MAUDE Adverse Event Report: PULMONX CORPORATION ZEPHYR ENDOBRONCHIAL VALVE

Model Number ZEPHYR 5.5 DM EDC

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

During a bronchoscopic lung volume reduction procedure with zephyr valves, the hub with sizing wings on the zephyr 5.5 dm endobronchial delivery catheter (edc) was detached while measuring and sizing the airways.This hub was recovered and removed from the patient.The physician was able to successfully complete the procedure with a new catheter.

• Brand Name: ZEPHYR ENDOBRONCHIAL VALVE
• Type of Device: 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: 18368223
• MDR Text Key: 331295395
• Report Number: 3007797756-2023-00225
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907031215
• UDI-Public: (01)00811907031215(10)506462V50(17)251020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZEPHYR 5.5 DM EDC
• Device Catalogue Number: EDC-TS-5.5-DM
• Device Lot Number: 506462-V5.0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2023
• 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