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

Catalog Number	VC10A256F60
Medical Device Problem Codes	Insufficient Heating (1287); Nonstandard Device (1420); Difficult to Remove (1528)
Health Effect - Clinical Codes	Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2026
Type of Reportable Event	Serious Injury
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
On (b)(6) 2026, a patient underwent radio frequency ablation procedure using the venclose catheter.During to the procedure, it was reported that upon initiation, the catheter failed to reach adequate temperature for effective treatment, with the generator displaying abnormal blue line patterns.During the final treatment cycle, the catheter had difficult to withdraw, with partial intimal tissue disruption observed.The patient experienced shock sensations during the final cycle.Additionally, the generator displayed inconsistent cycle data, recording 160 seconds of treatment with only 5 cycles, indicating inaccurate cycle counting.The procedure was completed using another catheter.The current status of the patient is unknown.
Event or Problem Description
On (b)(6) 2026, a female patient underwent a radio frequency ablation procedure using the venclose catheter.During the procedure, it was reported that upon initiation, the catheter failed to reach adequate temperature for effective treatment, with the generator displaying abnormal blue line patterns.During the final treatment cycle, the catheter was difficult to withdraw, with partial intimal tissue disruption observed.Patient experienced an atypical sensation during treatment; no electrical shock reported.Additionally, the generator displayed inconsistent cycle data, recording 160 seconds of treatment with only 5 cycles, indicating inaccurate cycle counting.The procedure was completed using the same catheter.The patient was reported to be stable, with no reported patient injury.The patient was scheduled for follow up with the hospital, including repeat imaging, to determine whether any additional treatment would be necessary.
Additional Manufacturer Narrative
H11: this supplemental report is submitted to correct an error in the previously submitted reports.The initial mdr and supplemental report 1 listed an incorrect manufacturing location (g1).The correct manufacturing location for this device is viant costa rica, s.A.No new event information is being reported in this supplement.As the lot number for the device was provided, a review of the device history records was performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.G1, g3.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.

• 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: 25690477
• Report Number: 3011879048-2026-00056
• Device Sequence Number: 13179112
• Product Code: GEI
• UDI-Device Identifier: 00858254006008
• UDI-Public: (01)00858254006008(11)251103(17)271014(10)88282704
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 09/23/2026

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: 88282704
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• 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: 06/09/2026
• Supplement Date Received by Manufacturer: 08/17/2026; 09/21/2026; 09/23/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 09/10/2026; 09/22/2026; 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female