MAUDE Adverse Event Report: VENCLOSE, INC. VENCLOSE SYSTEM DIGIRF GENERATOR; RADIOFREQUENCY ABLATION (RFA) GENERATOR

Catalog Number	VCRFG1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: the device is not returning.As of the date of this report, the final investigation remains pending.A supplemental report will be submitted upon completion of the investigation.The manufacturer was informed by the reporting facility that a total of (10) separate patient occurrences of ehit were identified following procedures using the venclose catheter and venclose generator serial number (b)(6).This mdr pertains only to the individual patient occurrence described in section b5.Separate mdrs will be submitted for each additional reported occurrence.These related events are being tracked under manufacturer internal complaint/pr record pr#(b)(4).Section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
The facility reported that this patient developed an endovenous heat induced thrombosis (ehit) following a venous ablation procedure performed using the venclose catheter in conjunction with the venclose generator.The event was identified post procedure during the facility¿s follow up assessment.No additional patient specific clinical details were provided at the time of this report.
Additional Manufacturer Narrative
H11: manufacturing review: a dhr and manufacturing review was not required as the event was determined to be expected, and the investigation did not identify any manufacturing and or service-related issues.Investigation summary: the venclose generator serial number was received at the bd bard global service and repair.The venclose generator was visually inspected upon receipt and was found to be in good physical condition.The etl label is missing due to it not being implemented at the time of manufacturing.The device was functionally tested and passed the test during evaluation where the generator was received with software version 3.17.No other anomalies were identified.Therefore, the investigation is determined to be inconclusive for the reported multiple instances of ehits.The root cause for the reported multiple instances of ehits cannot be determined as the problem could not be tested for the reported event.Labeling review: the labelling / packaging review was not required as the reported event is not associated with a labelling, packaging, or use related issue.A1, b1, b5, d4 (medical device expiration date, unique identifier (udi) #), g2, g3, h4, h6 (method, conclusion).Section a through f: the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
On (b)(6) 2025, a patient underwent a venous ablation procedure performed using the venclose catheter in conjunction with the venclose system digirf generator.The facility reported that this patient developed an endovenous heat induced thrombosis (ehit).The event was identified post procedure during the facilitys follow up assessment.No additional patient specific clinical details were provided at the time of this report.However, the current status of the patient is unknown.

• Brand Name: VENCLOSE SYSTEM DIGIRF GENERATOR
• Common Device Name: RADIOFREQUENCY ABLATION (RFA) GENERATOR
• Manufacturer (Section D): VENCLOSE, INC.; 2750 n. first street; 2nd floor, #221; san jose CA 95131
• Manufacturer (Section G): VENCLOSE, INC.; 2750 n. first street; 2nd floor, #221; san jose CA 95131
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 24206606
• Report Number: 3011879048-2026-00026
• Device Sequence Number: 12146077
• Product Code: GEI
• UDI-Device Identifier: 00858254006022
• UDI-Public: (01)00858254006022(17)491016
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VCRFG1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Unknown
• Patient Weight: 71 KG