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

Model Number VC-10A2.5-6F-60

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

Patient Problems Burn(s) (1757); Ulcer (2274)

Event Date 08/16/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.Investigation review of the manufacturing records for this device was completed and no issues were identified that could have lead to the adverse event reported.Complaints will continue to be monitored for any trends.

Event Description

A patient had a right gsv ablation procedure performed on (b)(6) 2021.There were no error codes, anatomy was normal and there were no notable observations regarding the catheter or the procedure.On (b)(6) 2021, the patient reported drainage with no pain at the right upper medial calf access site.Patient was seen in the office on (b)(6) 2021 and presented with a superficial ulcer of the skin at the access site.The wound was white in color with no drainage.Silvadene cream was prescribed for the wound.On (b)(6) 2021, patient reported minimal discomfort and the wound appears to be healing.

• 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: 12484742
• MDR Text Key: 271878937
• Report Number: 3011879048-2021-00019
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00858254006008
• UDI-Public: (01)00858254006008(10)49882342(11)210323(17)230323
• 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: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2023
• Device Model Number: VC-10A2.5-6F-60
• Device Catalogue Number: N/A
• Device Lot Number: 49882342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2021
• 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
• Patient Age: 52 YR
• Patient Weight: 79