MAUDE Adverse Event Report: Venclose, Inc. Venclose EVSRF Catheter; Venous Catheter

Catalog Number	VC10A256F60
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.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) 2026, a patient underwent a radio frequency ablation procedure using the venclose catheter.During to the procedure, the separation of catheter outer components resulting in exposure of internal components.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): Viant Costa Rica, S.A.; pq zona franca metropolitana; edificio 2c; barreal de heredia CA 40104 ; CS 40104
• Manufacturer Contact: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 25440063
• Report Number: 3011879048-2026-00055
• Device Sequence Number: 14965549
• Product Code: GEI
• UDI-Device Identifier: 00858254006008
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/22/2026

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: VC10A256F60
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• 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: 05/21/2026
• Supplement Date Received by Manufacturer: 07/22/2026; 09/21/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 07/27/2026; 09/22/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown