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

Model Number	8211
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be issued after the investigation is complete.
Event or Problem Description
As reported: the guardian ii valve became faulty and wouldn't allow equipment to pass through, hence damaging a stent.Valve and equipment removed, causing a larger then expected blood loss (300-400ml) for the procedure.No injury to patient.
Additional Manufacturer Narrative
Guardian was returned for evaluation.No damages were observed on the returned unit.A device history review was completed.No deviations or non conformances noted.It is unknown if the stent delivery system was deflated completely prior to being advanced or if the high-pressure seal (rotolock) was completely opened.Ifu states the following two precautions: balloons and stent delivery systems should be completely deflated before being advanced/ withdrawn through the hemostasis valve to avoid damage to the devices.Failure to open the guardian ii or the guardian ii nc high-pressure seal fully, prior to inserting/ withdrawing a diagnostic/interventional device, could cause damage to the device.Additional information was requested from the account.A response was received.It is unknown if the rotolock was secured or rotated.No injury noted with the patient.No other medical intervention was done due to this issue.Based on the information, the most likely root cause of the issue is undeterminable.No product failure was observed.

• Brand Name: GUARDIAN II
• Common Device Name: HEMOSTASIS VALVE
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564300
• MDR Report Key: 12334298
• Report Number: 2134812-2021-00060
• Device Sequence Number: 20011800
• Product Code: DTL
• UDI-Device Identifier: 10841156101923
• UDI-Public: 10841156101923
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K122301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/16/2023
• Device Model Number: 8211
• Device Catalogue Number: FH101
• Device Lot Number: 60532
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown