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

Model Number HUS-C26N

Device Problem Failure to Eject (4010)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 315208338
• Report Number: 3004450998-2023-00034
• Device Sequence Number: 1
• Product Code: OAZ
• UDI-Device Identifier: 00896506002187
• UDI-Public: 00896506002187
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: HDE H060002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2023
• 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): Hospitalization