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

Model Number	ZEPHYR 5.5 EDC
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2019, the patient underwent a bronchoscopy procedure with zephyr valve placement in the left lower lobe (lul) based on ct.A chartis assessment was performed in the lll and gave a negative collateral ventilation reading.A zephyr 5.5 endobronchial delivery catheter (edc) was used to size the airways and deploy a zephyr valve.During the valve sizing portion of the case, one of the sizing wings on the catheter fell off inside the patient.The loose sizing wing was found and suctioned out through the bronchoscope.A replacement catheter was used for the rest of the case and five valves were placed in the lll.

• Brand Name: ZEPHYR ENDOBRONCHIAL DELIVERY CATHETER
• Common Device Name: ENDOBRONCHIAL VALVE
• Manufacturer (Section D): PULMONX CORPORATION; 700 chesapeake drive; redwood city CA 94063
• MDR Report Key: 8869489
• Report Number: 3007797756-2019-00086
• Device Sequence Number: 18986817
• Product Code: NJK
• UDI-Device Identifier: 00811907030720
• UDI-Public: (01)00811907030720(10)504301V40(17)210308
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2019

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: 03/08/2021
• Device Model Number: ZEPHYR 5.5 EDC
• Device Catalogue Number: EDC-TS-5.5
• Device Lot Number: 504301-V4.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 88