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

Model Number	ZEPHYR 4.0-J 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	05/04/2021
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 for the right upper lobe.A zephyr 4.0-j endobronchial delivery catheter (edc) was inserted, and once visualized, it was noticed that one large sizing wing sheared off.The damaged device was successfully removed and the detached wing was removed with forceps.A new zephyr 4.0-j edc was used to complete the procedure uneventfully, without any significant delay.

• Brand Name: ZEPHYR ENDOBRONCHIAL DELIVERY CATHETER (EDC)
• Common Device Name: ENDOBRONCHIAL VALVE
• MDR Report Key: 11898744
• Report Number: 3007797756-2021-00106
• Device Sequence Number: 19153658
• Product Code: NJK
• UDI-Device Identifier: 00811907030621
• UDI-Public: (01)00811907030621(10)504821V50(17)220309
• 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): 05/26/2021

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: 03/09/2022
• Device Model Number: ZEPHYR 4.0-J EDC
• Device Catalogue Number: EDC-TS-4.0-J
• Device Lot Number: 504821-V5.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2020
• 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