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

Model Number VC-10A2.5-6F-100

Device Problems Display or Visual Feedback Problem (1184); Communication or Transmission Problem (2896)

Patient Problem Burn(s) (1757)

Event Date 09/21/2022

Event Type  Injury  

Manufacturer Narrative

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

An ablation procedure was performed.It was stated that a distance of 2.5 cm should be treated.A 2.5 cm was set on the generator and was also displayed on the generator.However, a longer distance than 2.5 cm was treated which was contrary to the display.The heating element treated a distance of 10 cm.As a result, the patient has skins burns.

• 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: 15644769
• MDR Text Key: 302165968
• Report Number: 3011879048-2022-00007
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00858254006015
• UDI-Public: (01)00858254006015(10)46995262(11)201124(17)221124
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2022
• Device Model Number: VC-10A2.5-6F-100
• Device Catalogue Number: N/A
• Device Lot Number: 46995262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• 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): Other