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 07/29/2020

Event Type  malfunction  

Event Description

On (b)(6) 2020, the patient underwent a bronchoscopic lung volume reduction (blvr) procedure with zephyr valves.While attempting to insert the zephyr 4.0-j endobronchial delivery catheter (edc) into an airway through the bronchoscope while the bronchoscope was severely articulated, the edc met resistance and was eventually forced into the airway.Once the edc entered the airway, it was observed that a small piece of the housing on the distal end had broken away from the catheter.The edc was removed and they opted to use a new zephyr 4.0-j edc.The territory manager reminded the physician and support team to advance the edc to the end of the bronchoscope prior to articulating the bronchoscope.There were no further issues during the procedure.The broken fragment was not located or retrieved.

• Brand Name: ZEPHYR ENDOBRONCHIAL DELIVERY CATHETER
• Type of Device: ENDOBRONCHIAL VALVE
• Manufacturer (Section D): PULMONX CORPORATION; 700 chesapeake drive; redwood city, ca
• MDR Report Key: 10455217
• MDR Text Key: 204876801
• Report Number: 3007797756-2020-00194
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030621
• UDI-Public: (01)00811907030621(10)504579V50(17)211014
• Combination Product (y/n): N
• PMA/PMN Number: P180002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2021
• Device Model Number: ZEPHYR 4.0-J EDC
• Device Catalogue Number: EDC-TS-4.0-J
• Device Lot Number: 504579-V5.0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2019
• 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: 77 YR
• Patient Weight: 99