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

Model Number ZEPHYR 4.0-J EDC

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

The zephyr 4.0-j 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 0.1% or 1:1,000.

Event Description

On (b)(6) 2018, the patient underwent a bronchoscopic lung volume reduction (blvr) procedure with the initial zephyr endobronchial valve placement.Two days after the procedure on (b)(6) 2018, the patient had achieved no reduction in lung volume and the physician decided to perform another bronchoscopy on this date.During the procedure, the physician decided to remove a zephyr valve from the apical segment of the right upper lobe and replace it with a new zephyr valve.Forceps were inserted through the bronchoscope and used to remove the valve.Once the valve was removed, a zephyr 4.0-j endobronchial delivery catheter (edc) was inserted to measure the airway.At this time, a small fragment was observed in the airway which was one of the four sizing wings (or diameter gauges) that had detached from the zephyr edc.The physician used forceps to remove the detached sizing wing.Subsequently, a zephyr 4.0 endobronchial valve was loaded into the zephyr 4.0-j endobronchial delivery catheter and placed in the apical segment of the right upper lobe and there were no issues.Patient is doing well and stable.

• 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: 8210852
• MDR Text Key: 132783133
• Report Number: 3007797756-2019-00001
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030621
• UDI-Public: (01)00811907030621(10)504109V50(17)200911
• 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: 01/02/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2020
• Device Model Number: ZEPHYR 4.0-J EDC
• Device Catalogue Number: EDC-TS-4.0-J
• Device Lot Number: 504109-V5.0
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2018
• 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: 77 YR
• Patient Weight: 68