MAUDE Adverse Event Report: VALVE IN CARTRIDGE, 6MM; SPIRATION VALVE

Model Number	HUS-V6
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At date of report, valve remains in patient.Valve was not removed.
Event or Problem Description
Patient experiencing air leak had three spiration valves placed in left upper lobe: size 7 in apical; size 7 in anterior; size 6 in apical posterior.After discharge from hospital, patient developed covid-19 and post-op appointment was delayed.Patient was subsequently scheduled for valve removal.Healthcare provider was able to easily visualize two of the valves in the left upper lobe, and successfully remove the size 7 in the apical and size 7 in the anterior segments, but had difficulty visualizing the size 6 in the apical posterior segment.Using a pediatric bronchoscope the healthcare provider could see that the valve had migrated distally and attempted numerous times to grasp the valve and retrieve it, but was unsuccessful.At this time, it was deemed best to hold the procedure and have the patient get repeat imaging to evaluate the valve location.Following repeat ct chest scan, healthcare provider decided not to remove the valve as a possible thoracotomy may be required.

• Brand Name: VALVE IN CARTRIDGE, 6MM
• Common Device Name: SPIRATION VALVE
• MDR Report Key: 11345902
• Report Number: 3004450998-2021-00008
• Device Sequence Number: 13773983
• Product Code: OAZ
• UDI-Device Identifier: 00896506002095
• UDI-Public: 00896506002095
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: HDE H060002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2021

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 Model Number: HUS-V6
• Device Lot Number: WS100657-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 02/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other