MAUDE Adverse Event Report: VENCLOSE, INC. VENCLOSE SYSTEM DIGIRF GENERATOR; RADIOFREQUENCY ABLATION (RFA) GENERATOR

Catalog Number VCRFG1

Device Problems Communication or Transmission Problem (2896); Inappropriate or Unexpected Reset (2959); Power Problem (3010)

Patient Problem Pain (1994)

Event Date 02/05/2024

Event Type  malfunction  

Manufacturer Narrative

As the serial number for the device was provided, a review of the device history records will be 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 of 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.Device pending return.

Event Description

It was reported that during an rf ablation procedure, while performing last 2.5cm segment, the generator allegedly switched from the treatment screen to the home screen to back to the treatment screen.It was further reported that generator display switch allegedly changes from 2.5cm back to 10cm.Reportedly, the doctor allegedly pressed the button on the handle to stop the treatment, but the treatment cycle continued, hence, pulled the power cable from the generator to stop the treatment.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a device history record and manufacturing review was not required as the event was not determined to be unexpected and the investigation did not identify any manufacturing and/or service-related issues.Investigation summary: the venclose generator, was received for evaluation.The generator was visually inspected upon receipt and found to be in poor physical condition.The generators shroud is bent and scratched at the right rear side of the housing due to use of the device.The generator was received at the depot with software version 3.17.The reported issue that the generator switched from the treatment screen to the home screen, and back to the treatment screen could not be replicated.The generator stayed on the treatment screen with a functional test fixture connected.The reported issue that the generator switched from 2.5cm to 10cm during a treatment could not be replicated.The generator does not switch between settings without the screen being pressed.The reported issue that the treatment cycle continued after pressing the button on the handle to stop the treatment could not be replicated.The generator stopped during the heating cycle on both settings when the button on the functional test fixture was pressed.Therefore, the investigation is determined to be unconfirmed for all the reported issues.The root cause for the reported issues could not be determined.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: section a through f - the information provided by bd represents all of 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 Description

It was reported that during an rf ablation procedure, just prior to performing the last 2.5cm segment treatment, the generator allegedly switched from the treatment screen to the home screen and then again back to the treatment screen.It was further reported that generator displayed that it was in 2.5cm ablation mode, but when the physician pressed the button on the catheter to initiate the last ablation, generator display switch allegedly changes from 2.5cm back to 10cm.Reportedly, the physician allegedly pressed the button on the handle to stop the treatment, but the treatment cycle continued, hence, pulled the power cable from the generator to stop the treatment.There was no reported patient injury.

• Brand Name: VENCLOSE SYSTEM DIGIRF GENERATOR
• Type of Device: RADIOFREQUENCY ABLATION (RFA) GENERATOR
• 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: 18834429
• MDR Text Key: 336878040
• Report Number: 3011879048-2024-00003
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00858254006022
• UDI-Public: (01)00858254006022
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VCRFG1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1