MAUDE Adverse Event Report: VENCLOSE, INC. VENCLOSE EVSRF CATHETER; VENOUS CATHETER

Catalog Number	VC10A256F60
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a radio frequency ablation procedure using the venclose catheter.During the procedure, the generator screen displayed a red x when the catheter was plugged in.The procedure was completed using another catheter.There was no reported patient injury.
Additional Manufacturer Narrative
H11: the catheter lot number was provided by the user facility.A review of the device history records was conducted, verifying the lot met all release criteria prior to being released for distribution.The physical device was not returned for evaluation.No photos were provided for review.A voluntary field action has been initiated for venclose¿ rf ablation catheters.Software version 3.35 of the venclose¿ digirf¿ generator includes a self-check feature intended to identify internal wiring issues in venclose¿ rf ablation catheters.This check runs after the catheter is connected to the generator and before the procedure screen appears.If the catheter fails this check, the generator displays a ¿red x¿ without an error code, rendering the catheter unusable.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 being submitted to clarify that the field action was initiated on the capital equipment (venclose¿ digirf¿ generator), not on the disposable catheter referenced in the initial report.The catheter was not the subject of the recall.The recall information and associated z-number previously included in the initial mdr are being removed as they do not apply to this device.Manufacturer report numbers for the generator involved in the field action are 3011879048-2025-00076 through 3011879048-2025-00091.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) 2025, a patient underwent a radio frequency ablation procedure using the venclose catheter.During the procedure, the generator screen displayed a red x when the catheter was plugged in.The procedure was completed using another catheter.There was no reported patient injury.

• Brand Name: VENCLOSE EVSRF CATHETER
• Common Device Name: VENOUS CATHETER
• 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: 23213172
• Report Number: 3011879048-2025-00046
• Device Sequence Number: 9066170
• Product Code: GEI
• UDI-Device Identifier: 00858254006008
• UDI-Public: (01)00858254006008(17)270321(10)81536712
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: VC10A256F60
• Device Lot Number: 81536712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 12/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2638-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown