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	03/10/2026
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.The investigation of the reported event is currently underway.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.
Event or Problem Description
A patient underwent a radiofrequency ablation procedure using the venclose system digirf generator.During procedure, it was reported that when a venclose catheter was opened and plugged into the venclose generator, it started to display error 53 not recognizing the catheter.Generator is in software version 3.35.Additional information was provided and stating there was a large red x with error code 53.There was no patient injury reported.

• 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: 24797113
• Report Number: 3011879048-2026-00041
• Device Sequence Number: 21509546
• Product Code: GEI
• UDI-Device Identifier: 00858254006022
• UDI-Public: (01)00858254006022(17)280728
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K160754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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
• Device Lot Number: US000896
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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