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

Model Number 8211

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2016

Event Type  Injury  

Event Description

Patient 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 ½ compressions when the patient spoke.Angiogram again performed (airlock resolved and patient had resolution of flow to timi - 3) patient was transferred to icu.Patient was moving extremities on command, awake, no complaint of chest pain.The patient did well and was discharged home on (b)(6) 2016.

• Brand Name: GUARDIAN II
• Type of Device: HEMOSTASIS VALVE
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: jacob schultz ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564230
• MDR Report Key: 6046792
• MDR Text Key: 58056916
• Report Number: 2134812-2016-00074
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: M20682110
• UDI-Public: M20682110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2019
• Device Model Number: 8211
• Device Lot Number: 43192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention