MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC GUARDIAN II NC INTRO TORQUE; HEMOSTATSIS VALVE

Catalog Number 8216

Device Problem Leak/Splash (1354)

Patient Problem Arrhythmia (1721)

Event Date 01/05/2024

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that: on (b)(6) 2024, dr.Was fixing a cx artery with a guardian hemostasis valve.There was an air leak into the vessel an air embolus was noted in the circumflex artey and patient went into arrythmias.Patient had cpr initiated and she was intubated, and the case was aborted to stabilize patient.Patient went to the icu, still intubated, but expected to recover.Additional information received on 08jan2024: the guardian apparently was leaking some blood from the proximal hub the rotolock was in the open position for the duration of the case the patient had a minimal blood leak during the case.Additional information received on 08jan2024: patient is extubated and doing fine, as of today.

Event Description

It was reported that: on (b)(6) 2024, dr.Was fixing a cx artery with a guardian hemostasis valve.There was an air leak into the vessel an air embolus was noted in the circumflex artery and patient went into arrythmias.Patient had cpr initiated and she was intubated, and the case was aborted to stabilize patient.Patient went to the icu, still intubated, but expected to recover.Additional information received on 08jan2024: the guardian apparently was leaking some blood from the proximal hub the rotolock was in the open position for the duration of the case the patient had a minimal blood leak during the case.Additional information received on 08jan2024: patient is extubated and doing fine, as of today.

Manufacturer Narrative

(b)(4).No returned product evaluation could be completed as there was no product returned for this complaint.It is unknown if any damages were present on the unit.Guardian is supplied unit from harmac medical.A dhr review was completed for lot 73894.No issues or non-conformities were noted.Case details were reviewed.Customer stated," dr.Was fixing a cx artery with a guardian (8216) hemostasis valve.The device apparently malfunctioned and leaked air into the vessel.An air embolus was noted in the circumflex artery and patient went into arrythmias.Patient had cpr initiated and she was intubated, and the case was aborted to stabilize patient." as per the additional information received, guardian was leaking some blood from proximal hub.The leak was not significant.The rotolock was in open position for rest of the case.It is unknown what could have caused the air embolus into the vessel.The ifu states the following warning and precaution.- do not inject any fluid into the guardian ii or guardian ii nc if air bubbles are present as air embolism may occur.- connection system should be rated for appropriate pressures for use with the guardian ii or guardian ii nc.Failure to ensure that the connection system is rated appropriately may result in device damage or malfunction.- do not introduce medical devices without depressing the cap, as this could cause seal damage resulting in leakage or embolization.- do not close the guardian ii or the guardian ii nc high-pressure seal when the low-pressure seal is open (i.E.When the cap is depressed) as this may result in device damage and air ingress.Air embolism is identified as a potential adverse effect that may be associated with the use of guardian.Patient was intubated and shifted to icu.On (b)(6) 2024, patient was extubated and doing fine.Based on the information, the most likely root cause of the issue is undeterminable.The der process will continue to monitor for any similar events.

• Brand Name: GUARDIAN II NC INTRO TORQUE
• Type of Device: HEMOSTATSIS VALVE
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18622604
• MDR Text Key: 334321673
• Report Number: 2134812-2024-00003
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 10841156101367
• UDI-Public: 10841156101367
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 8216
• Device Lot Number: 73894
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 70 KG