MAUDE Adverse Event Report: BLUEGRASS VASCULAR TECHNOLOGIES, INC. SURFACER INSIDE-OUT ACCESS CATHETER SYSTEM; REVERSE CENTRAL VENOUS RECANALIZATION SYSTEM

Model Number	600200/A
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	02/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the intended use of the device, right femoral vein access was obtained, the surfacer 10fr workstation was advanced over the guidewire wire and positioned within the stump of the occlusion.Using fluoroscopy for visualization, the surfacer device was introduced into the 10f workstation.The surfacer device was then advanced through the occlusion until the device tip and window were above the clavicle.The c-arm was adjusted to localize the tip of the device within the center of the externally placed target.The device was adjusted, the needle guide was deployed and needle wire advanced.A 7f sheath was advanced over the wire and secured using a hemostat.The catheter was then pulled into the body with the tip positioned in the right atrium by retracting the surfacer device.A post-procedure ultrasound of the neck identified a hematoma and catheter position was deemed suboptimal.After manipulating catheter, the hematoma appeared to be enlarged.The catheter was removed and the arterial defect repaired by balloon tamponade.Balloon was inflated to nominal pressure and maintained for 10 minutes.Upon balloon deflation, arteriogram showed no contrast extravasation at the site of defect.The patient was observed for another 15 minutes and a repeat angiogram confirmed hemostasis at the site.

• Brand Name: SURFACER INSIDE-OUT ACCESS CATHETER SYSTEM
• Common Device Name: REVERSE CENTRAL VENOUS RECANALIZATION SYSTEM
• Manufacturer (Section D): BLUEGRASS VASCULAR TECHNOLOGIES, INC.; san antonio TX 78249
• MDR Report Key: 16573078
• Report Number: MW5115813
• Device Sequence Number: 5691198
• Product Code: QJH
• UDI-Device Identifier: 00860003451601
• UDI-Public: 00860003451601
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: 600200/A
• Device Catalogue Number: 600200/A
• Device Lot Number: BVT042622-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Hispanic