MAUDE Adverse Event Report: PULMONX CORPORATION ZEPHYR ENDOBRONCHIAL VALVE

Model Number ZEPHYR 4.0 EDC

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 09/19/2023

Event Type  malfunction  

Event Description

During a bronchoscopic lung volume reduction procedure on september 19, 2023, with zephyr valves, the tip of the housing of the zephyr 4.0 endobronchial delivery catheter (edc) was damaged.The catheter was blocked at the endoscope's outlet.The cause of the damage is unknown.The endoscope used was a reusable olympus 2.8 mm.

• 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: 17953257
• MDR Text Key: 325909016
• Report Number: 3007797756-2023-00186
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030515
• UDI-Public: (01)00811907030515(10)506535V50(17)251212
• 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: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZEPHYR 4.0 EDC
• Device Catalogue Number: EDC-TS-4.0
• Device Lot Number: 506535-V5.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2022
• 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