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

Model Number 8211

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 08/19/2016

Event Type  Injury  

Event Description

A (b)(6) female presented to the cardiac catheterization lab for a left heart catheterization with coronary angiography angioplasty, intracoronary stent placement following a non-stemi mi on (b)(6) 2016.During post stent angiogram air embolization had occurred with timi 0 flow in the left coronary artery.Angiographic "air lock" was present.Epinephrine was administered and cpr initiated but only lasted 1-1 1/2 compressions when the pt spoke.Angiogram again performed (airlock resolved and pt had resolution of flow to timi - 3) pt was transferred to icu.Pt was moving extremities on command, awake, no complaint of chest pain.The pt did well and was discharged home on (b)(6) 2016.

• Brand Name: GUARDIAN II HEMOSTASIS VALVE
• Type of Device: GUARDIAN
• Manufacturer (Section D): VASCULAR SOLUTIONS INC.; minneapolis MN
• MDR Report Key: 5982935
• MDR Text Key: 55906428
• Report Number: MW5065054
• Device Sequence Number: 1
• Product Code: DTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 8211
• Device Catalogue Number: N20682110
• Device Lot Number: 43192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 6 FR IKARI IL4.0 GUIDE CATHETER, MFR: TERUMO MED; ABBOTT .014 PILOT 200 190CM GUIDE WIRE; ABBOTT 2.0 MM X 12 MM MINI TREK RX BALLOON ; ABBOTT 2.5 MM X 12 MM TREK RX BALLOON; ABBOTT 2.75 MM X 15 MM TREK RX BALLOON; ABBOTT 3.0 MM X 18 MM VISION RX STENT; ABBOTT ASAHI FIELDER XT .014" 190CM; ABBOTT ASAHI GRANDSPLAM .014" 180CM; ABBOTT ASAHI PROWATER .014" 180CM; ABBOTT ASAHI SION BLUE .014" 180CM GUIDEWIRE; ABBOTT XIENCE ALPINE STENT 3.0MM X 23MM; CORDIS EMPIRA BALLOON 2.5 MM X 15MM ; MEDTRONIC 6 FR ALI GUIDE CATHETER; MEDTRONIC RESOLUTE STENT 3.0 MM X 22 MM; MERIT MEDICAL INC .035MM 210CM 3MM J WIRE; MERIT MEDICAL MONARCH-25 INFLATION KIT; TERUMO MEDICAL 6 FR RADIAL ACCESS KIT GLIDE SHEATH; TERUMO MEDICAL 6 FR RADIAL TIG 4.0 CATHETER; TERUMO MEDICAL FINECROSS MICROCATHETER; TERUMO MEDICAL RUNTHROUGH NS .014" 180CM; VASCULAR SOLUTIONS 6 FR. GUIDE LINER
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 50