MAUDE Adverse Event Report: VENCLOSE, INC. VENCLOSE RF ABLATION CATHETERS; RF CATHETER

Model Number	VC-10A2.5-6F-100
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for this device was completed and no issues were identified.If additional information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
The patient underwent a routine endovenous radiofrequency ablation procedure of the greater saphenous vein (gsv) located on the right leg.During the procedure a skin burn occurred below the right knee, but the skin burn was not seen by the physician until the follow-up appointment.The date of the follow-up appointment is unknown.The procedure was completed without any issues and patient is doing well.The patient was given burn salve at follow-up appointment.No other treatment or medication was given to the patient.The clinic indicated the device did not malfunction during the procedure therefore, the device was discarded after the procedure.

• Brand Name: VENCLOSE RF ABLATION CATHETERS
• Common Device Name: RF CATHETER
• Manufacturer (Section D): VENCLOSE, INC.; 2570 n. first street; 2nd floor, #221; san jose CA 95131
• MDR Report Key: 8313920
• Report Number: 3011879048-2019-00001
• Device Sequence Number: 62411
• Product Code: GEI
• UDI-Device Identifier: 00858254006190
• UDI-Public: 00858254006190
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K160754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: VC-10A2.5-6F-100
• Device Catalogue Number: VC-10A2.5-6F-100
• Device Lot Number: 6066401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other