MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NGEN RF GENERATOR; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_NGEN RF GENERATOR

Device Problems Communication or Transmission Problem (2896); Mechanical Jam (2983)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a ngen generator and the work station showed a brief flicker of ¿lost communication'.The message came up every few seconds then flashed away after less than a second.An error also appeared on a secondary monitor relating the connection window multiple times as well.The medical team suspected that the ethernet cables were loose, so they rewired all three systems (console, primary, and secondary) but the error message was still flickering.The medical team discovered that the ngen's foot pedal was stuck, so they switched to a smartablate generator and continued the procedure.The procedural delay was approximately 80 minutes.No patient consequences were reported.After the procedure, the ngen issue was resolved by re-seating the ngen ethernet cable between the workstation and ngen.The ngen also received a software update to v2.0b sw.

Manufacturer Narrative

E1 initial reporter phone: (b)(6).Per fda request, mdr submissions for the ngen rf generator are to be reported with pma details of the catheter used along with the ngen rf generator.However, no catheter information was provided.Follow-up was performed and no additional information was provided.Therefore, processed with the ablation catheter information of the smart touch sf.The hardware investigation has begun but it has not been completed at this time.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On (b)(6) 2024, bwi received additional information indicating that ablation did not continue.The physician determined that continuing ablation would be risky due to the stuck foot pedal.As a result, they did not ablate.Therefore, there was no patient risk.Due to the delay, the medical team increased dosage to maintain heparinsation.The medical team then continued the procedure without ablation.No patient consequences were reported.Since ablation ceased, the pedal problem will not be considered reportable.No further details or reports will be provided regarding this event.Manufacturer's reference number: (b)(4).

• Brand Name: UNK_NGEN RF GENERATOR
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): FLEX; hamatechet 2; migdal haemek ; IS
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18678430
• MDR Text Key: 336308434
• Report Number: 2029046-2024-00446
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NGEN RF GENERATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• 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