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

Model Number HUS-V6

Device Problems Gas/Air Leak (2946); Migration (4003)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

At date of report, valve remains in patient.Valve was not removed.

Event 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
• Type of Device: SPIRATION VALVE
• Manufacturer (Section D): GYRUS ACMI, INC; 6675 185th avenue ne; redmond WA 98052
• MDR Report Key: 11345902
• MDR Text Key: 233975515
• Report Number: 3004450998-2021-00008
• Device Sequence Number: 1
• Product Code: OAZ
• UDI-Device Identifier: 00896506002095
• UDI-Public: 00896506002095
• Combination Product (y/n): N
• PMA/PMN Number: HDE H060002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other