MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC. GUARDIAN II; HEMOSTASIS VALVE

Model Number	8210
Health Effect - Clinical Code	ST Segment Elevation (2059)
Date of Event	05/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event or Problem Description
A guardian ii device was used in a patient procedure.The physician was working on an rca lesion and had a guidewire and guidelines in place as it was used a large air bubble went down the right coronary artery.Patient became symptomatic with st elevation.The patient was fine in the end but required vasodilators.

• Brand Name: GUARDIAN II
• Common Device Name: HEMOSTASIS VALVE
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 5704107
• Report Number: 2134812-2016-00039
• Device Sequence Number: 16315199
• Product Code: DTL
• UDI-Device Identifier: M20682100
• UDI-Public: M20682100
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K092711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 01/31/2019
• Device Model Number: 8210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2016
• Initial Report FDA Received Date: 06/07/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention