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

Catalog Number	VC10A256F60
Medical Device Problem Codes	Contamination (1120); Material Deformation (2976); Excessive Heating (4030)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a patient underwent a radiofrequency ablation procedure using the venclose catheter.During the procedure, the catheter allegedly heated above the temperature displayed on the generator, and a thick clot formed on the tip of the catheter that could not be removed as expected.Additionally, patient experienced pain and presented to the emergency department; ultrasound showed no ehitt or dvt.There was no reported patient injury.
Event or Problem Description
On (b)(6)2026, a patient underwent a radiofrequency ablation procedure using the venclose catheter.During the procedure, the catheter allegedly heated above the temperature displayed on the generator, and a thick clot formed on the tip of the catheter that could not be removed as expected.Additionally, patient experienced pain and presented to the emergency department; ultrasound showed no ehitt or dvt.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2026, a patient underwent a radiofrequency ablation procedure using the venclose catheter.During the procedure, the catheter allegedly heated above the temperature displayed on the generator, and a thick clot formed on the tip of the catheter that could not be removed as expected.Additionally, it was reported that the patient experienced pain and presented to the emergency department (ed).The current status of the patient is unknown.
Additional Manufacturer Narrative
H11: additional information was received, and the file was reassessed for reportability.Based on the medical affairs team assessment and the follow up information received, the event does not meet the criteria for a serious injury.Follow up documentation notes no ehitt or dvt identified on ultrasound, no reported medical intervention beyond evaluation, and no evidence of lasting injury, permanent impairment, or damage to a body structure or function.Therefore, the complaint was downgraded from serious injury to not reportable.Although the event is now considered non reportable, an initial mdr had already been submitted based on the information available at the time of reporting.However, following review of the additional information received, the final reportability assessment has been updated to not reportable.B5, e1, g3, h6 (patient).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.
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.Additional information was received, and the file was reassessed for reportability.As a blood clot was identified on the distal tip of the catheter, the event should have been documented as a contamination issue.Therefore, the complaint was reassessed and determined to be reportable as a malfunction.B1, g1, g3, h6 (device).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.
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 device has been returned to the manufacturer for evaluation.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.

• 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: 50190625
• Report Number: 3011879048-2026-00063
• Device Sequence Number: 12286840
• Product Code: GEI
• UDI-Device Identifier: 00858254006008
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/17/2026

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: 89827871
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: 08/10/2026; 09/17/2026
• Initial Report FDA Received Date: 08/10/2026
• Supplement Report FDA Received Date: 08/25/2026; 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown