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	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.Photo was provided for review.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
It was reported that during a radiofrequency ablation procedure using the venclose system digirf generator.It was reported that the catheters did not work and were it was throwing a red x when connected to the venclose generator.Received confirmation from the facility a day later stating the generator is running in 3.35 software version.Additional information was received stating occurred during catheter initialization.The patient was treated with an additional catheter that worked.There was no patient injury reported.
Event or Problem Description
A patient underwent a radiofrequency ablation procedure using the venclose system digirf generator.During the procedure, it was reported that the catheters did not work and it was throwing a red x when connected to the venclose generator.Received confirmation from the facility a day later stating the generator is running in 3.35 software version.Additional information was received stating that the issue occurred during catheter initialization.The patient was treated with an additional catheter that worked.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: this event is determined to be unexpected; therefore, a dhr review and manufacturing review is required.Investigation summary: the venclose generator serial number (b)(6) was received at the bd bard global service & repair.One photo of the venclose generator ((b)(4) - generator software version.Jpg) was provided by the customer.In the photo, the generator was placed the on the table.The venclose logo was displayed on the generator, and the catheter was connected on the device.Also, the home screen displaying the software version being 3.35.No other visual anomalies were noted of the internal component.Based on photo review, the reported issue is inconclusive as the exact circumstances at the time of the reported event cannot be verified from the provided photo.The venclose generator was visually inspected upon receipt and was found to be in good physical condition.The device was received with software version 3.35, and it was downgraded to 3.17 for testing.The device was functionally tested and passed the tests after downgrading the software.The short tests results are 10cm = 20.42 v 2.5cm = 6.64 v 10cm short test = pass 2.5cm short test = pass.No other anomalies were identified.Therefore, the investigation is determined to be confirmed for the redx error on software version 3.35 issue.The root cause for redx error on software version 3.35 issue could not be determined based on the provided information.Labeling review: the labelling/packaging review was not required as the reported event is not associated with a labelling, packaging, or use related issue.D4 (unique identifier (udi) #), g3, h6 (method, result, conclusion).Section a through f: the information provided 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.

• 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: 24602893
• Report Number: 3011879048-2026-00037
• Device Sequence Number: 8569115
• Product Code: GEI
• UDI-Device Identifier: 00858254006022
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,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: 07/02/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 06/03/2026; 09/11/2026; 09/21/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 06/04/2026; 09/15/2026; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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