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 01/21/2019

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 placement.A zephyr 4.0-j endobronchial delivery catheter (edc) was inserted to size the airway.While sizing the airway, one of the four sizing wings (or diameter gauges) had detached from the zephyr 4.0-j edc and was retrieved.A new zephyr edc was used and there were no other 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: 8354654
• MDR Text Key: 139569678
• Report Number: 3007797756-2019-00008
• 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: 02/19/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Manufacturer Received: 01/21/2019
• Initial Date FDA Received: 02/20/2019
• 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: 76 YR
• Patient Weight: 58