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	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
See attached.- attachment: [per 2019-0243_evaluation summary_2020-01-14.Pdf].
Event or Problem Description
Product investigation was completed and is attached with this follow-up report.
Event or Problem Description
On (b)(6) 2019, the physician loaded a zephyr 5.5-lp endobronchial valve into a zephyr 5.5 dualmark endobronchial delivery catheter, which was then passed through a bronchoscope and deployed in the posterior segment of the patient's left upper lobe (lul).After deployment, the physician pulled the zephyr catheter out of the bronchoscope.He then passed the zephyr catheter back down without a zephyr valve loaded to measure the anterior segment of the lul.As the zephyr catheter exited the bronchoscope working channel, a sizing wing became detached and was visualized loose in the airway.The physician suctioned the sizing wing fragment through the bronchoscope and an airway inspection showed no remaining foreign bodies.On jan.3, 2020, the zephyr catheter was returned to pulmonx.At the time of this report, a product investigation is ongoing and a follow-up report will be submitted.

• 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: 9554498
• Report Number: 3007797756-2020-00004
• Device Sequence Number: 2019499
• Product Code: NJK
• UDI-Device Identifier: 00811907031222
• UDI-Public: (01)00811907031222(10)504437V50(17)210708
• 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,Followup
• Report Date (Section B): 01/14/2020

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: 07/08/2021
• Device Model Number: ZEPHYR 5.5 DUAL MARK EDC
• Device Catalogue Number: EDC-TS-5.5-DM
• Device Lot Number: 504437-V5.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 01/14/2020
• 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: 68 YR
• Patient Weight: 76