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	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a radiofrequency venous ablation procedure using the venclose system digirf generator.It was reported that the device displayed an error.Additional information was received stating device displayed a red x and error 53 when three different catheters were connected.The catheters worked fine when used with a different generator.Additional information was received, stating that the venclose generator was received at the service center with 3.35 software version installed.This confirms that the generator was operating on software version 3.35 when the red x with error 53 was displayed at the facility.The issue occurred during use but there was no reported injury to the patient.
Additional Manufacturer Narrative
H11: manufacturing review: a dhr and manufacturing review were not required as the event was not classified as an unexpected event, the investigation did not identify any manufacturing related issues, and no repeat failures were found during the service history review.Investigation summary: the venclose generator serial number (b)(6) 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 venclose was downgraded from 3.35 to 3.17 so that testing could occur.The etl label is missing due to it not being implemented at the time of manufacturing.The device was functionally tested and passed the tests during evaluation.The short test values are 10cm equal to 19.70v, 2.5cm equal to 5.88v, 10cm short test equal to pass and 2.5cm short test equal to pass.No other anomalies were identified.Therefore, the investigation is determined to be confirmed for the reported error 53 and red x issue.A definitive root cause for the reported error 53 and red x issue on 3.35v could not be determined based upon the provided information.Labeling review: the labeling/packaging review was not required as the reported event is not associated with a labeling, packaging, or use related issue.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.

• 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50427831
• Report Number: 3011879048-2026-00065
• Device Sequence Number: 10224507
• Product Code: GEI
• UDI-Device Identifier: 00858254006022
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 08/14/2026

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: 07/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 08/25/2026
• 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