MAUDE Adverse Event Report: Venclose, Inc. Venclose System digiRF Generator; Radiofrequency Ablation (RFA) Generator

Catalog Number	VCRFG1
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the serial number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.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
On (b)(6) 2026, a patient was prepped for a radio frequency ablation procedure using the venclose generator.Prior to the procedure, the venclose generator displayed a red x at catheter initialization after flushing.Venclose generator is in 3.35 software version.There was no patient involvement.

• 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): Minnetronix, Inc.; 1635 energy park dr.; 2nd floor, #221; st. paul MN 55108
• Manufacturer Contact: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 25212380
• Report Number: 3011879048-2026-00051
• Device Sequence Number: 10574040
• Product Code: GEI
• UDI-Device Identifier: 00858254006022
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VCRFG1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/27/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 06/26/2026; 09/21/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 06/30/2026; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown