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

Catalog Number	600200
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)
Date of Event	10/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient experienced post-procedure bleeding requiring intervention (sternotomy) following a procedure involving use of a demers catheter and the surfacer system.Physician from hospital in (b)(6) reported bleeding following the surfacer system procedure in whom a patient received vascular access via a demers catheter.The physician reported that the surfacer system procedure was conducted successfully following the ifu and no device malfunction was noted.After the procedure was completed, there was an acute drop in blood pressure and blood loss.Digital subtraction angiography (dsa) with contrast in both legs was utilized and contrast was visualized extraluminal in the right thorax, suspecting atrial injury.The patient stabilized and was transferred to the thoracic surgery department of the university hospital of kiel where a sternotomy was performed to address post-surgical bleeding.The bleeding ceased and the patient was in stable condition, and has recovered.The physician explained that the inserted demers catheter was too short and probably slipped out of the atrium.An experienced physician proctor was consulted regarding the case and asked whether use of the surfacer system may have caused or contributed to the bleeding.The expert responded that the surfacer system was not the cause of the massive bleeding, but may have contributed to the event.The clinical expert concluded that the selection of a catheter which was too short and had a split tip rather than straight tip was key to the event.Review of the information concluded that the surfacer system device performed as intended and without malfunction of the device.The operator's choice of vascular access catheter likely resulted in unintentional damage to the veins, resulting in post-operative bleeding.Bleeding is an anticipated risk in the ifu, which required intervention to prevent serious harm.After vascular repair was successfully completed the patient recovered from the procedure without any further adverse events.Fda safety report id# (b)(4).

• 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: 11236271
• Report Number: MW5099014
• Device Sequence Number: 2766229
• Product Code: QJH
• UDI-Device Identifier: 00860003451601
• UDI-Public: 00860003451601
• Combination Product (Y/N): Y
• 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): 01/22/2021
• 2 Devices were Involved in the Event: 1 2

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: 01/31/2021
• Device Catalogue Number: 600200
• Device Lot Number: BVT010818-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2021
• 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: 63 YR