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

Catalog Number VCRFG1

Device Problems Display or Visual Feedback Problem (1184); Inappropriate or Unexpected Reset (2959)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

H10: manufacturing review: a dhr 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: one venclose generator, serial number (b)(6) was received at the bd - bard global service & repair depot for evaluation.The generator was visually inspected upon receipt and was found to be in good physical condition.Upon functional testing, the generator passed all testing on the 2.5 and 10cm tests.The generator did not go blank or switch from 2.5cm to 10cm treatment length.Therefore, the investigation determined that unexpected treatment length reset and generator screen going blank are unconfirmed findings.A definitive root cause for the alleged issues could not be determined based upon the provided information.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.H10: d4 (expiration date: 12/2027) h11: 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 Description

It was reported that during an radiofrequency ablation procedure, the device allegedly would not operate in the 2.5cm option.It was further reported that when using the 2.5cm option, they would hit the power button on the catheter and the screen would allegedly go blank and default back to 10cm.They were unable to use the 2.5cm option.Reportedly, they grabbed a different generator and plugged in the same catheter, and it worked perfectly.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: 18746225
• MDR Text Key: 335808743
• Report Number: 3011879048-2024-00002
• Device Sequence Number: 1
• Product Code: GEI
• 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: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1