MAUDE Adverse Event Report: VENCLOSE, INC. VENCLOSE EVSRF CATHETER; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/15/2022

Event Type  Injury  

Manufacturer Narrative

Device did not malfunction during the procedure.The device lot number is unknown and the device was not returned for evaluation as the device was discarded.Complaints will continue to be monitored for any trends.If more information are provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2022, patient was treated for an rf ablation procedure on the l gsv.The catheter was reported to have been placed 3.5 cm from the sfj.An ehit 2 or ehit 3 was reported on (b)(6) 2022 during a follow-up exam.Patient was placed on xarelto.It was noted that a new rvt was assisting with the procedure.

• Brand Name: VENCLOSE EVSRF CATHETER
• Type of Device: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Manufacturer (Section D): VENCLOSE, INC.; 2570 n. first street; 2nd floor, #221; san jose CA 95131
• Manufacturer (Section G): VENCLOSE, INC.; 2570 n. first street; 2nd floor, #221; san jose CA 95131
• Manufacturer Contact: mai-ly wilcox ; 2570 n. first street; 2nd floor, #221; san jose, CA 95131 ; 8448346292
• MDR Report Key: 15396829
• MDR Text Key: 299660551
• Report Number: 3011879048-2022-00006
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention