MAUDE Adverse Event Report: GYRUS ACMI, INC. DEPLOYMENT CATHETER AND LOADER, 2.6; SPIRATION VALVE CATHETER AND LOADER

Model Number	HUS-C26N
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical staff reported there was no patient injury.Follow-up to obtain additional event information is ongoing.The deployment catheter and loader is being returned to the manufacturer for further investigation.No valves will be returned.
Event or Problem Description
Patient was to have spiration valves (hus-v9) placed for the treatment of air leak (date unknown).Physician used the spiration deployment catheter and loader (hus-c26n) to place the spiration valves.Valves could not be placed.Physician reported three wasted valves (hus-v9) due to a malfunctioning deployment catheter and loader (hus-c26n).Replacement devices were sent resulting in a 24-hour delay in procedure.No patient injury occurred.
Additional Manufacturer Narrative
Deployment catheter and loader was returned to gyrus acmi, inc.For evaluation.Initial inspection of the deployment catheter showed it was bent at the distal end.Further inspection of catheter tip showed a kinked/ bent stabilization wire.Upon opening the loader, two valves were found to be stuck in the loader.The valves were removed from the loader, indicating the second valve appears to have been forcibly loaded without deploying the first valve, leading to damage of the deployment catheter and the valves.
Event or Problem Description
Patient was to have spiration valves (hus-v9) placed for the treatment of air leak (date unknown).Physician used the spiration deployment catheter and loader (hus-c26n) to place the spiration valves.Valves could not be placed.Physican reported three wasted valves (hus-v9) due to a malfunctioning deployment catheter and loader (hus-c26n).Replacement devices were sent resulting in a 24-hour delay in procedure.No patient injury occurred.

• Brand Name: DEPLOYMENT CATHETER AND LOADER, 2.6
• Common Device Name: SPIRATION VALVE CATHETER AND LOADER
• Manufacturer (Section D): GYRUS ACMI, INC.; 6675 185th ave ne; redmond WA 98052
• Manufacturer (Section G): GYRUS ACMI, INC.; 6675 185th ave ne; redmond WA 98052
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16925146
• Report Number: 3004450998-2023-00034
• Device Sequence Number: 20534345
• Product Code: OAZ
• UDI-Device Identifier: 00896506002187
• UDI-Public: 00896506002187
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: HDE H060002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2023

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-C26N
• Device Lot Number: WS326739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 05/13/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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
• Patient Sex: Unknown