MAUDE Adverse Event Report: PULMONX CORPORATION ZEPHYR ENDOBRONCHIAL VALVE (EBV)

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 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

See attached.

Event Description

On (b)(6) 2019, patient underwent bronchoscopic lung volume reduction (blvr) procedure with zephyr endobronchial valve (ebv) placement.While the physician was measuring the airways for valve sizing with the zephyr 5.5 dual mark endobronchial delivery catheter (edc), one of the sizing wings was seen in the patient's airway.The damaged zephyr 5.5 dual mark edc was opened using proper technique and under the territory manager's observation.Gel lubrication was applied prior to insertion into the working channel of the bronchoscope, but significant resistance was evident as the catheter passed through the bottom of the bronchoscope's working channel and into the patient's airway.The torn off wing was removed via suction without incident, and a replacement delivery catheter was opened for use during the rest of the procedure.

• Brand Name: ZEPHYR ENDOBRONCHIAL VALVE (EBV)
• Type of Device: ENDOBRONCHIAL VALVE
• Manufacturer (Section D): PULMONX CORPORATION; 700 chesapeake drive; redwood city CA 94063
• Manufacturer Contact: leland keyt ; 700 chesapeake drive; redwood city, CA 94063 ; 6502160144
• MDR Report Key: 9440962
• MDR Text Key: 194475388
• Report Number: 3007797756-2019-00188
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907031222
• UDI-Public: (01)00811907031222(10)504556V50(17)210925
• 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: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2019
• 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: 59 YR