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	06/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the facility had a failed catheter when used with this venclose generator.The generator was confirmed to be in software version 3.35.Additional information was provided stating that during a procedure on (b)(6) 2026, using this venclose generator, a red x error with error 53 was displayed immediately after the catheter was connected.The catheter had not yet been inserted into the vein when the error occurred.The target treatment location was the great saphenous vein (gsv); the affected side was not specified.There was no patient involvement or impact reported.
Event or Problem Description
It was reported that the facility had a failed catheter when used with this venclose generator.The generator was confirmed to be in software version 3.35.Additional information was provided stating that during a procedure on (b)(6) 2026, using this venclose generator, a red x error with error 53 was displayed immediately after the catheter was connected.The catheter had not yet been inserted into the vein when the error occurred.The target treatment location was the great saphenous vein (gsv); the affected side was not specified.There was no patient involvement or impact reported.
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 (b)(6) was received at the bd-bard global service & repair.The venclose generator was visually inspected upon receipt and was found to be in good physical condition.The generator was received with software version 3.35, so it was downgraded to 3.17 for testing.The device was functionally tested and passed the tests during evaluation.The short tests values are 10cm equal to 20.45 v, 2.5cm equal to 6.71 v, 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 failed to read catheter issue.A definitive root cause for the reported red x software issue on the device 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.E1, g3, h6 (method, result, conclusion) 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.
Additional Manufacturer Narrative
H11: this supplemental report is submitted to correct an error in the previously submitted reports.The initial mdr listed an incorrect manufacturing location (g1).The correct manufacturing location for this device is minnetronix, inc.No new event information is being reported in this supplement.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 & repair.The venclose generator was visually inspected upon receipt and was found to be in good physical condition.The generator was received with software version 3.35, so it was downgraded to 3.17 for testing.The device was functionally tested and passed the tests during evaluation.The short tests values are 10cm equal to 20.45 v, 2.5cm equal to 6.71 v, 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 failed to read catheter issue.A definitive root cause for the reported red x software issue on the device 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.G1, g3 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): 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: 25823550
• Report Number: 3011879048-2026-00058
• Device Sequence Number: 16056651
• Product Code: GEI
• UDI-Device Identifier: 00858254006022
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 07/14/2026
• 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: 06/23/2026
• Supplement Date Received by Manufacturer: 08/13/2026; 09/21/2026
• Initial Report FDA Received Date: 07/15/2026
• Supplement Report FDA Received Date: 08/17/2026; 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