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	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zephyr 5.5 endobronchial delivery catheter (edc) device was discarded at the site and not returned to the manufacturer for investigation.The device was not evaluated and no root cause could be determined.It is possible that the bronchoscope being used for the procedure was not properly cleaned or was previously damaged.Other potential factors that can damage a zephyr endobronchial delivery catheter are tortuous anatomy, the working channel of the bronchoscope, or the catheter insertion and removal technique used by the user.From a review of similar occurrences from july 1, 2017 to january 2, 2019, there have been 3 complaints involving zephyr edc detached sizing wings.From july 1, 2017 - sept.30, 2018, (b)(4) zephyr endobronchial valves have been shipped, resulting in an estimated per valve complaint occurrence rate of (b)(4).This is below the predicted occurrence rate for this failure mode on the zephyr edc process fmea of (b)(4).
Event or Problem Description
On (b)(6) 2018, the patient underwent a bronchoscopy for chartis assessment and zephyr valve insertion for a bronchoscopic lung volume reduction (blvr) procedure.During the charis assessment, it was determined that the patient was negative for collateral ventilation in his right lower lobe and therefore, would receive zephyr valves.The patient received a total of 5 zephyr valves in his right lower lobe.During the procedure, a zephyr 5.5 endobronchial delivery catheter was inserted to measure the superior segment of the right lower lobe.As the delivery catheter came out of the bronchoscope, one of the four sizing wings (also called diameter gauges) from the delivery catheter had become detached and was visualized in the airway.The detached sizing wing was removed with forceps, and the zephyr 5.5 endobronchial delivery catheter determined that the zephyr 5.5 endobronchial valve would be the incorrect size for the airway diameter.As a result, the physician switched to the smaller sized zephyr 4.0 endobronchial delivery catheter for the remainder of the procedure with no issues.Patient is doing well and stable.

• 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: 8210747
• Report Number: 3007797756-2018-00015
• Device Sequence Number: 10813636
• Product Code: NJK
• UDI-Device Identifier: 00811907030720
• UDI-Public: (01)00811907030720(10)504049V40(17)200718
• 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): 01/02/2019

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: 07/18/2020
• Device Model Number: ZEPHYR 5.5 EDC
• Device Catalogue Number: EDC-TS-5.5
• Device Lot Number: 504049-V4.0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 01/02/2019
• 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: 60 YR
• Patient Weight: 73