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	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: the physical device was not returned, and no photographs or other objective evidence were provided for evaluation.As a result, the investigation could not confirm the reported failure, and no definitive root cause could be determined.A voluntary field action ¿ field work (service at customer location) ¿ 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.
Event or Problem Description
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.There was no reported patient injury.
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
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.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: 23213267
• Report Number: 3011879048-2025-00057
• Device Sequence Number: 8806828
• Product Code: GEI
• UDI-Device Identifier: 00858254006008
• UDI-Public: (01)00858254006008(17)270409(10)82246651
• 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,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: 82246651
• 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