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

Model Number 8210

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2015

Event Type  malfunction  

Event Description

Three devices seemed to be faulty.The valves did not close properly when pushed in.No patient impact was reported.

• Brand Name: GUARDIAN II
• Type of Device: HEMOSTASIS VALVE
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; maple grove MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: paul campbell ; 6464 sycamore court north; maple grove, MN 55369 ; 7637622560
• MDR Report Key: 5510403
• MDR Text Key: 40668540
• Report Number: 2134812-2016-00016
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2018
• Device Model Number: 8210
• Device Lot Number: 42108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Removal/Correction Number: 2134812-03/16/2016-001R
• Patient Sequence Number: 1
• Patient Outcome(s): Other