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

Model Number ZEPHYR 5.5 DUAL MARK EDC

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

The zephyr 5.5 dual mark edc device was unfortunately discarded and not returned to the manufacturer for investigation.As such, a complaint investigation could not be completed and a probable root cause could not be established.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 an edc are tortuous anatomy, the working channel of the bronchoscope, or the insertion and removal technique used by the user.In a separate lab notebook study (notebook no.2009-02, pages 99 - 113) investigating this issue of a detached edc sizing wing, a potential root cause for the failure mode observed in the zephyr 4.0-j edc device was confirmed.The zephyr 4.0-j edc is a different product model than the product (zephyr 5.5 dual mark edc) involved in this report.In this study, if a user improperly removes the device from the packaging card, i.E., does not follow the steps (step 1, step 2, and step 3) that are described in the instructions for use (100-0623/b) and numbered 1 - 3 on the packaging card, then the sizing wing and/or hub on the zephyr edc device may become damaged during the removal from the packaging.Specifically, if a user pulls on the catheter handle to remove the catheter without first releasing the tab securing the distal end (step 1), the sizing wing and/or hub may become damaged during removal.The testing in the lab notebook study demonstrated and confirmed that damage occurs to the sizing wing and/or hub if the zephyr 4.0-j edc device is improperly removed from the packaging card.From q3-2018 to (b)(6) 2019 (the date of this event), there have been 15 reported complaints involving zephyr edc detached sizing wings.From q3-2018 to q3-2019, 14,167 zephyr endobronchial valves have been shipped, resulting in an estimated per valve complaint occurrence rate of 0.1%.This is within the predicted occurrence rate for this failure mode on the zephyr ebv system use fmea (900-0047/g) of 1:100 to 1:1,000.

Event Description

On (b)(6) 2019, the patient underwent a bronchoscopic lung volume reduction procedure with zephyr valves.During the procedure while sizing the airway, one of the sizing wings on the zephyr 5.5 dual mark endobronchial delivery catheter fell off inside the airway.The loose sizing wing inside the airway was located and removed.

• 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: 9560993
• MDR Text Key: 194476607
• Report Number: 3007797756-2020-00005
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907031222
• UDI-Public: (01)00811907031222(10)504556V50(17)210926
• 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: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2021
• Device Model Number: ZEPHYR 5.5 DUAL MARK EDC
• Device Catalogue Number: EDC-TS-5.5-DM
• Device Lot Number: 504556-V5.0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2019
• 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: 79