MAUDE Adverse Event Report: GYRUS ACMI, INC. SPIRATION VALVE SYSTEM; VALVE, PULMONARY

Model Number SVS-V9-00

Device Problems Positioning Failure (1158); Mechanical Jam (2983); Material Split, Cut or Torn (4008); Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2021

Event Type  malfunction  

Event Description

When opening the 9mm valve this nurse placed it into the device for placement into the catheter and when putting it into the catheter the stent would not exit the valve box that it came in.So this nurse opened the box and saw that the valve was very damaged (please see actual valve that was kept).When inserting the 6mm valve into the sheath the valve device acted like it did not want to push the valve into the deploying device.So when opening up the valve mechanism it was noted that the plastic around the valve legs was torn and not attached to the leg of the valve.Due to this the valve could not be placed in the patient.Chart review: total of 9 values successfully placed, including three, 9mm spiration valves.Discovered immediately prior to patient insertion therefore no effect on patient outcome.

• Brand Name: SPIRATION VALVE SYSTEM
• Type of Device: VALVE, PULMONARY
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana ave north; brooklyn park MN 55445
• MDR Report Key: 13250746
• MDR Text Key: 283767000
• Report Number: 13250746
• Device Sequence Number: 1
• Product Code: NJK
• 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: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SVS-V9-00
• Device Lot Number: WS123127-01
• 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: 11/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Weight: 59 KG