MAUDE Adverse Event Report: ZEPHYR ENDOBRONCHIAL VALVE (EBV)

Model Number	ZEPHYR 5.5 EDC
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During the implantation procedure on (b)(6) 2020, the distal tip of the catheter broke off inside the patient.Graspers were used to remove the foreign object.There was no patient injury.

• Brand Name: ZEPHYR ENDOBRONCHIAL VALVE (EBV)
• Common Device Name: ENDOBRONCHIAL VALVE
• MDR Report Key: 10759585
• Report Number: 3007797756-2020-00241
• Device Sequence Number: 3657105
• Product Code: NJK
• UDI-Device Identifier: 00811907031222
• UDI-Public: (01)00811907031222(10)505065V50(17)220626
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2020

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: 06/16/2022
• Device Model Number: ZEPHYR 5.5 EDC
• Device Catalogue Number: EBV-TS-5.5-DM
• Device Lot Number: 505065
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/29/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2020
• 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: Hospitalization; Required Intervention