MAUDE Adverse Event Report: VENCLOSE, INC. VENCLOSE EVSRF CATHETER; VENOUS CATHETER

Catalog Number	VC10A256F60
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: the device was returned and is currently undergoing evaluation.As of the date of this report, the final investigation remains pending.A supplemental report will be submitted upon completion of the investigation.A voluntary field action ¿ field work (service at customer location) ¿ has been initiated for venclose¿ rf ablation catheters.Software version 3.35 of the venclose¿ digirf¿ generator includes a self-check feature intended to identify internal wiring issues in venclose¿ rf ablation catheters.This check runs after the catheter is connected to the generator and before the procedure screen appears.If the catheter fails this check, the generator displays a ¿red x¿ without an error code, rendering the catheter unusable.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) 2025, a patient underwent a radio frequency ablation procedure using the venclose catheter.Prior to the procedure, the generator screen displayed a red x when the catheter was plugged in.The procedure was completed using another catheter.There was no patient contact.
Event or Problem Description
On (b)(6) 2025, a patient underwent a radio frequency ablation procedure using the venclose catheter.Prior to the procedure, the generator screen displayed a red x when the catheter was plugged in.The procedure was completed using another catheter.There was no patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested because the lot is part of a larger capa investigation and situation analysis sa.A voluntary field action field work service at customer location has been initiated for venclose rf ablation catheters software version 335 of the venclose digirf generator includes a selfcheck feature intended to identify internal wiring issues in venclose rf ablation catheters this check runs after the catheter is connected to the generator and before the procedure screen appears if the catheter fails this check the generator displays a red x without an error code rendering the catheter unusable.Investigation summary: two venclose vcrf 60cm catheter was received for evaluation in sample 1 2 the device appeared to have residue on the outer housing a complete circumferential break was noted on the catheter shaft proximal to the strain relief multiple kinks were noted throughout the catheter shaft the break and kinks likely occurred due to the manner in which the device was packaged for return therefore the break and kinks are considered incidental during visual inspection n both samples upon opening the handle all wires were noted to be intact and in place the proximal battery was partially seated and distal battery was fully seated within the battery holder when the original batteries removed both battery and battery pad noted to be clean under uv inspection in sample 1 slight glow anomalies were observed on the distal pad and no glow anomalies were observed in proximal pad and in batteries in sample 2 no glow anomalies were observed in battery and battery pads this will be considered incidental during functional testing in sample 1 2 the catheter was plugged into the generator as received with original batteries and remained on the home screen venclose logo new batteries were inserted into generator without sd card and displayed error 53 red x new batteries were inserted catheter was plugged into generator with sd card brand all button was pressed and the generator screen displayed catheter type already programmed p xx new batteries were inserted into generator with sd card and displayed error 53 red x although an error 53 was displayed during the functional evaluation the investigation is unconfirmed for nonstandard device and confirmed for red x failed selfcheck the red x was identified when a branding sd card was inserted the generator displayed catheter type already programmed with a random sequence of characters when the selfcheck fails using software 335v the generator screen will display a red x and the software will corrupt the catheter branding making the device unusable if the catheter is unplugged and plugged back into the generator error 53 will then be displayed as the branding is no longer valid a flushing test was performed after unplugging catheter with an inhouse syringe with water was attached to the male luer lock of the catheter flushing completed successfully three long and three short tests were completed successfully no errors were presented therefore based on findings the investigation is determined to be unconfirmed for the identified error 53 and the investigation is determined to be confirmed for the reported red x issue displayed on screen the definitive root cause for the reported red x cannot be determined and the root cause for the identified error 53 issue cannot be determined.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (method, result, conclusion).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) 2025, a patient underwent a radio frequency ablation procedure using the venclose catheter.Prior to the procedure, the generator screen displayed a red x when the catheter was plugged in.The procedure was completed using another catheter.There was no patient contact.
Additional Manufacturer Narrative
H11: this supplemental report is being submitted to clarify that the field action was initiated on the capital equipment (venclose¿ digirf¿ generator), not on the disposable catheter referenced in the initial report.The catheter was not the subject of the recall.The recall information and associated z-number previously included in the initial mdr are being removed as they do not apply to this device.Manufacturer report numbers for the generator involved in the field action are 3011879048-2025-00076 through 3011879048-2025-00091.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): VENCLOSE, INC.; 2750 n. first street; 2nd floor, #221; san jose CA 95131
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23213264
• Report Number: 3011879048-2025-00058
• Device Sequence Number: 8806826
• Product Code: GEI
• UDI-Device Identifier: 00858254006008
• UDI-Public: (01)00858254006008(17)270311(10)81441841
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2025

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: 81441841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 10/10/2025; 12/01/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 11/07/2025; 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2638-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown