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

Model Number	ZEPHYR 5.5 DUAL MARK EDC
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
See attached.
Event or Problem 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)
• Common Device Name: ENDOBRONCHIAL VALVE
• Manufacturer (Section D): PULMONX CORPORATION; 700 chesapeake drive; redwood city CA 94063
• MDR Report Key: 9440962
• Report Number: 3007797756-2019-00188
• Device Sequence Number: 11186454
• Product Code: NJK
• UDI-Device Identifier: 00811907031222
• UDI-Public: (01)00811907031222(10)504556V50(17)210925
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P180002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2019

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR