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

Catalog Number	VC-10A25-6F-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported skin burn could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required 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 radiofrequency ablation procedure using the venclose catheter.Following the procedure, the patient experienced second degree burns and presented to a general practitioner the following day.The patient status is unknown.
Event or Problem Description
On (b)(6)2026, a patient underwent a radiofrequency ablation procedure using the venclose catheter.Following the procedure, the patient experienced second degree burns and presented to a general practitioner the following day.The patient status is unknown.
Additional Manufacturer Narrative
H11: this supplemental report is submitted to correct an error in the previously submitted reports.The initial mdr captured 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.Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported skin burn could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G1, g3.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.

• 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: 25794280
• Report Number: 3011879048-2026-00057
• Device Sequence Number: 21079349
• Product Code: GEI
• UDI-Device Identifier: 00858254006015
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: VC-10A25-6F-100
• 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: 06/25/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 07/13/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown