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 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

[(b)(4)].

Event Description

On (b)(6) 2019, the patient underwent a bronchoscopic lung volume reduction (blvr) procedure with zephyr endobronchial valve (ebv) placement.A zephyr 4.0-j endobronchial delivery catheter (edc) was used to size the airways and successfully deployed a zephyr valve.The zephyr 4.0-j edc was removed from the bronchoscope with the bronchoscope still in position in the patient.A second zephyr 4.0 valve was loaded into the zephyr 4.0-j edc, and the catheter was inserted into the bronchoscope which was articulated to reach lb1-2.While trying to advance further, resistance was met, and the catheter withdrawn.At that time, it was noticed that the housing on the zephyr 4.0-j edc was damaged but still attached, and one of the four sizing wings (also called diameter gauges) was detached.No device fragment had exited the bronchoscope and due to mucus, there were multiple suctions performed through the bronchoscope.The conclusion from the treating physician was that if the sizing wing detached in the bronchoscope it was removed during suction because there was no device fragment remaining in the patient.A new zephyr 4.0-j edc and zephyr 4.0 valve were used, and there were no further issues.

• 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: 8374322
• MDR Text Key: 139569701
• Report Number: 3007797756-2019-00015
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Date Manufacturer Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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: 72 YR
• Patient Weight: 39