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

Model Number 8210

Device Problems Air Leak (1008); Connection Problem (2900)

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

Event Date 09/30/2015

Event Type  malfunction  

Event Description

A guardian device was used in a procedure.The staff said they tried to connect the guardian device to acist tubing but it would not get a tight connection and air bubbles went into the system.The air bubbles were observed in the acist system and did not enter the patient's vascular system.There was no patient impact reported for this event.

• 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; maple grove MN 55369
• Manufacturer Contact: jacob schultz ; 6464 sycamore court north; maple grove, MN 55369 ; 7636564230
• MDR Report Key: 5192475
• MDR Text Key: 30406477
• Report Number: 2134812-2015-00038
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• PMA/PMN Number: K122301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 10/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2018
• Device Model Number: 8210
• Device Lot Number: 40675
• Date Manufacturer Received: 09/30/2015
• Date Device Manufactured: 05/28/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1