FDA Adverse Event Injury Summary report: N

SURFACER INSIDE-OUT ACCESS CATHETER SYSTEM

MDR report key: 16876901 · Received May 4, 2023

Report

Report Number
MW5117264
Event Type
Injury
Date Received
May 4, 2023
Date of Event
April 4, 2023
Report Date
May 1, 2023
Manufacturer
BLUEGRASS VASCULAR TECHNOLOGIES, INC.
Product Code
QJH
UDI-DI
00860003451601
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
BIOMEDICAL ENGINEER
Health Professional
Yes

Narratives

Description of Event or Problem · 0

A 71 YR. OLD, AFRICAN-AMERICAN FEMALE WITH END STAGE KIDNEY DISEASE (ESKD) PRESENTED WITH A TYPE 3 OCCLUSION OF THE SUPERIOR VENA CAVA (SVC) AND LEFT BRACHIOCEPHALIC STENT IN PLACE. THE SURFACER SYSTEM PROCEDURE WAS UTILIZED TO OBTAIN CENTRAL VENOUS ACCESS AND FACILITATE CATHETER INSERTION INTO THE CENTRAL VENOUS SYSTEM. FOLLOWING THE SURFACER PROCEDURE, PLACEMENT OF A TUNNELED DIALYSIS CATHETER WAS PLANNED FOR SUBSEQUENT PLACEMENT OF THE HERO GRAFT FOR HEMODIALYSIS TREATMENT. USING STANDARD SELDINGER TECHNIQUE, RIGHT FEMORAL VEIN ACCESS WAS ACHIEVED. AN 0.035MM WIRE WAS INSERTED FOLLOWED BY A DIAGNOSTIC CATHETER AND THEN A 12 FR. X 45 CM REINFORCED SHEATH WHICH WAS ADVANCED TO ABOVE THE RIGHT ATRIUM AND INTO THE SVC. THE SURFACER 10FR WORKSTATION WAS INSERTED INSIDE THE 12FR SHEATH FOLLOWED BY THE SURFACER DEVICE. USING ROTATIONAL ANGIOGRAPHY, THE SURGEON NOTED THAT THE SURFACER DEVICE ADVANCEMENT COULD POTENTIALLY PIERCE THE RIGHT SUBCLAVIAN ARTERY. THE WORKSTATION AND THE SURFACER SYSTEM WERE REPOSITIONED, AND ROTATIONAL ANGIOGRAPHY PREDICTED A SAFER COURSE THAT WOULD NOT INJURE THE SUBCLAVIAN ARTERY. THE SURFACER WAS THEN ADVANCED THROUGH THE OCCLUSION TO THE HEAD OF THE CLAVICLE. THE NEEDLE GUIDE WAS EXTENDED AND THE NEEDLE WIRE FROM THE SURFACER WAS ADVANCED THROUGH THE SKIN ABOVE THE RIGHT CLAVICLE. ONCE THE NEEDLE GUIDE SAFELY RETRACTED, THE SURGEON BEGAN TO ADVANCE THE NEEDLE WIRE TO ALLOW FOR A 5 FR SHEATH TO BE PLACED. CONTRAST WAS INJECTED INTO THE SHEATH WHILE PULLING THE SHEATH BACK TO OBSERVE ANY EXTRAVASATION. CONTRAST WAS NOTED TO ENHANCE THE PLEURAL SPACE. THE PATIENT REMAINED STABLE AND THE 5 FR SHEATH AS REPOSITIONED INTO THE SVC. THE NEEDLE WIRE CONTINUED TO BE ADVANCED BUT LEFT NO WIRE AT THE BACK END OF THE SURFACER TO PULL THE WIRE BACK INTO THE SYSTEM. GIVEN INJURY TO THE PLEURA, THE SURGEON DECIDED TO PLACE A PORT INSTEAD OF THE PLANNED TUNNELED DIALYSIS CATHETER FOR A REDUCED CATHETER DIAMETER. THE PORT WAS PLACED OVER THE SURFACER NEEDLE WIRE USING A 7.5 FR PEEL-A-WAY SHEATH INSTEAD OF USING THE 16FR SHEATH IN THE SURFACER KIT. THE SURFACER DEVICE, WITH THE NEEDLE WIRE EXTENDED AND 10FR WORKSTATION WERE THEN REMOVED FROM THE BODY VIA THE RIGHT FEMORAL VEIN. AS SOON AS THE PEEL-A-WAY SHEATH WAS REMOVED LEAVING ONLY THE PORT CATHETER IN POSITION, THE PATIENT'S BLOOD PRESSURE DROPPED AND HEMOTHORAX WAS NOTED. A CHEST TUBE WAS INSERTED. BALLOON POSITIONING IN THE SVC ACROSS THE AREA OF OUTWARD PUNCTURE OF THE SURFACER DEVICE DID NOT STABILIZE THE PATIENT. ARTERIOGRAPHY DEMONSTRATED EXTRAVASATION FROM THE RIGHT INTERNAL MAMMARY ARTERY. COIL EMBOLIZATION WAS PERFORMED WHICH STABILIZED THE PATIENT ALONG WITH BLOOD TRANSFUSION. LIMITED THORACOSCOPY EVACUATED HEMOTHORAX AND SHE WAS TRANSFERRED TO THE ICU. TWO DAYS LATER CT IMAGING WAS DONE SHOWING RETAINED HEMOTHORAX BUT NO ACTIVE BLEEDING AND REPEAT THORACOSCOPY WAS DONE. AS OF (B)(6) 2023, THE PATIENT WAS STABLE BUT CONTINUED TO BE HOSPITALIZED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
764651 SURFACER INSIDE-OUT ACCESS CATHETER SYSTEM REVERSE CENTRAL VENOUS RECANALIZATION SYSTEM QJH BLUEGRASS VASCULAR TECHNOLOGIES, INC. 600200/A BVT111722-01 00860003451601

Patients

Seq Age Sex Outcome Treatment
1 71 YR Female Required Intervention