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 08/07/2021

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 ssv 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 was seen in the office and reported that 2 days prior, she started seeing a red erythema at the access site.The physician noted a thin rim wound that is white at the access site.Keflex was prescribed for 7 days as well as the use of medihoney on the wound.On (b)(6) 2021, an oozing mucous rim measuring 0.8x0.3cm surrounded by a 2cm erythema was observed at the access site of the right ssv.Silvadene cream was prescribed for the wound and medihoney.On (b)(6) 2021, 2cm wound was still present.On (b)(6) 2021, the patient was seen in the office and the wound size was smaller, 5x10mm.The wound was described as superficial and shallow with no drainage.Patient continued using medihoney.

• 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
• MDR Report Key: 12555956
• MDR Text Key: 281608059
• Report Number: 3011879048-2021-00022
• 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
• PMA/PMN Number: K160754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• 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
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR