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

Model Number 8216

Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913)

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

Event Date 05/20/2016

Event Type  malfunction  

Event Description

Dr.(b)(6) was doing a cto case using a guardian hemostasis valve with a turnpike catheter that was through the valve.While he was drawing an act blood sample through stopcock with extension tubing, air was being sucked into guardian and into the syringe.He checked all connections.To make sure they were tight.A while later, he was drawing another act off and same thing happened again while turnpike was in.He drew back on the syringe slowly.He drew two act's total during case.

• Brand Name: GUARDIAN II NC
• 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: 5721511
• MDR Text Key: 48254074
• Report Number: 2134812-2016-00042
• 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: Physician
• Type of Report: Initial
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2018
• Device Model Number: 8216
• Device Lot Number: 42113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization