MAUDE Adverse Event Report: ZEPHYR ENDOBRONCHIAL DELIVERY CATHETER (EDC); ENDOBRONCHIAL VALVE

Model Number	ZEPHYR 4.0 EDC
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, the patient underwent a bronchoscopic lung volume reduction (blvr) procedure with zephyr valves.During the delivery of a zephyr valve, the physician pushed a zephyr 4.0 edc outside of the bronchoscope.When he pulled the zephyr edc back into the bronchoscope, a sizing wing detached from the catheter in the airway of the lung.After pulling out the zephyr edc from the bronchoscope and trying again, two more sizing wings became detached in the airway of the lung.All the detached wings were immediately retrieved with forceps.The zephyr edc was getting stuck at the hub when getting pulled back into the bronchoscope.A new zephyr edc was used to complete the procedure without any substantial delay and there was no impact on the procedure or outcome of the patient.

• Brand Name: ZEPHYR ENDOBRONCHIAL DELIVERY CATHETER (EDC)
• Common Device Name: ENDOBRONCHIAL VALVE
• MDR Report Key: 11681847
• Report Number: 3007797756-2021-00060
• Device Sequence Number: 16897793
• Product Code: NJK
• UDI-Device Identifier: 00811907030522
• UDI-Public: (01)00811907030522(10)505179V50(17)220904
• 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
• Serviced by Third Party (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): 04/12/2021

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: 09/04/2022
• Device Model Number: ZEPHYR 4.0 EDC
• Device Catalogue Number: EDC-TS-4.0
• Device Lot Number: 505179-V5.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 04/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention