MAUDE Adverse Event Report: ZEPHYR ENDOBRONCHIAL DELIVERY CATHETER; 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	08/18/2021
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.The physician had used the zephyr 4.0 endobronchial delivery catheter to size airways in the right upper lobe (rul) and right middle lobe (rml) and deliver three valves.One of the sizing wings of the catheter was detached, and the fragment was not found.It was not clear if the sizing wing fell off inside the patient, was inside of the bronchoscope and subsequently removed, or if it was removed from the patient while mucus and blood were cleared from the airway.The physician had difficulty accessing the apical segment of the rul.The physician used a new zephyr 4.0-j catheter and was able to successfully complete the procedure.

• Brand Name: ZEPHYR ENDOBRONCHIAL DELIVERY CATHETER
• Common Device Name: ENDOBRONCHIAL VALVE
• MDR Report Key: 12457153
• Report Number: 3007797756-2021-00244
• Device Sequence Number: 17160475
• Product Code: NJK
• UDI-Device Identifier: 00811907030522
• UDI-Public: (01)00811907030522(10)505292V50(17)221116
• 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): 09/10/2021

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: 11/16/2022
• Device Model Number: ZEPHYR 4.0 EDC
• Device Catalogue Number: EDC-TS-4.0
• Device Lot Number: 505292-V5.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2020
• 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