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

Model Number 8210

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

Patient Problem ST Segment Elevation (2059)

Event Date 03/30/2016

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A guardian ii hemostasis valve was used during a patient procedure.During the procedure, air entered the patient.The air was recognized immediately and the patient was treated.

• 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: renee michael ; 6464 sycamore court north; maple grove, MN 55369 ; 7636564366
• MDR Report Key: 5637219
• MDR Text Key: 44609621
• Report Number: 2134812-2016-00030
• Device Sequence Number: 1
• Product Code: DTL
• 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: Other
• Type of Report: Initial
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 8210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention