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

Catalog Number	VC10A256F60
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: b3: the actual date of event is unknown.The date received by manufacturer was entered into the date of event field.D4 medical device lot # 88167642 was reported; however, this is not a lot # manufactured for the reported catalog # vc10a256f60.D4: medical device expiration date: unknown, h4: device manufacture date: unknown.As the lot number for the device was not provided, a review of the device history records could not be performed.The sample has not been returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow up report will be submitted as applicable.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 radiofrequency ablation procedure using a venclose catheter.During the procedure, it was found that the battery was depleted, the 60 cm catheter was not recognized by the generator when connected, and a hole was observed in the package.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: 50716238
• Report Number: 3011879048-2026-00068
• Device Sequence Number: 9852427
• Product Code: GEI
• UDI-Device Identifier: 00858254006008
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 09/21/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/10/2026
• Supplement Report FDA Received Date: 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