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

Model Number ZEPHYR 5.5 EDC

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2019

Event Type  malfunction  

Event 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
• Type of Device: ENDOBRONCHIAL VALVE
• Manufacturer (Section D): PULMONX CORPORATION; 700 chesapeake drive; redwood city CA 94063
• Manufacturer Contact: leland keyt ; 700 cheseapeake drive; redwood city, CA 94063 ; 6502160144
• MDR Report Key: 8869489
• MDR Text Key: 177376399
• Report Number: 3007797756-2019-00086
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030720
• UDI-Public: (01)00811907030720(10)504301V40(17)210308
• 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: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2019
• 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
• Patient Age: 65 YR
• Patient Weight: 88