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 01/21/2020

Event Type  malfunction  

Event Description

On (b)(6) 2020, the patient underwent a bronchoscopic lung volume reduction procedure with zephyr valves.During the procedure, one of the sizing wings on the zephyr 5.5 dual mark endobronchial delivery catheter fell off inside the patient.The loose sizing wing was immediately retrieved from the patient.

• 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: 9671992
• MDR Text Key: 222489357
• Report Number: 3007797756-2020-00020
• 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: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• 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: 01/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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: 73 YR