MAUDE Adverse Event Report: SPIRATION, INC. SPIRATION VALVE SYSTEM DEPLOYMENT CATHETER AND LOADER, 2.6; ONE-WAY AIR-LEAK VALVE

Model Number HUS-C26N

Device Problem Activation Problem (4042)

Patient Problem Insufficient Information (4580)

Event Date 06/25/2020

Event Type  malfunction  

Event Description

Loaded a size 9 endobronchial valve in deployment catheter.Valve did not deploy when button pushed in.

• Brand Name: SPIRATION VALVE SYSTEM DEPLOYMENT CATHETER AND LOADER, 2.6
• Type of Device: ONE-WAY AIR-LEAK VALVE
• Manufacturer (Section D): SPIRATION, INC.; 6675 185th avenue n.e.; redmond WA 98052
• MDR Report Key: 10649326
• MDR Text Key: 210446210
• Report Number: 10649326
• Device Sequence Number: 1
• Product Code: OAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HUS-C26N
• Device Catalogue Number: W03863-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Weight: 55