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 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

See attached.- attachment: [per 2019-0243_evaluation summary_2020-01-14.Pdf].

Event Description

Product investigation was completed and is attached with this follow-up report.

Event 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)
• 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: 9554498
• MDR Text Key: 181864614
• Report Number: 3007797756-2020-00004
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907031222
• UDI-Public: (01)00811907031222(10)504437V50(17)210708
• 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,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2019
• 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: 68 YR
• Patient Weight: 76