MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NGEN RF GENERATOR; CATHETER, ELECTRODE RECORDING

Catalog Number D138401

Device Problem Mechanical Jam (2983)

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

Event Date 09/22/2022

Event Type  malfunction  

Event Description

It was reported that an unknown patient underwent atrial fibrillation (afib) ablation procedure with an ngen rf generator, worldwide configuration, foot pedal was stuck.Catheter used were- qdot, cs and pentaray.It was reported that during the first ablation in qdot mode / 40watt after 15 seconds, they had to stop the ablation due to patient issue (not related to biosense product).They released the foot pedal but could still hear the audible noise of the ablation and the graph viewer/ablation mode was still red.They tried to stop manually but it didn't work.They had to turn off to power supply to stop the ablation.The bwi company representative thinks it could be a software issue as when the data showed that the ablation stopped when they released the pedal (the data have been uploaded and are available if needed).They restarted the ngen only and everything was working fine after that.Procedure was completed.No patient consequences.5 minutes delay reported.The foot pedal got stuck (pressed) and continue ablating, it was not physically pressed.But when physician released it, ablation did not stop.Manual stop in ngen monitor did not stop neither.We turned it down disconnecting power supply from ngen console.After restarting, it did ablate again when pressed.The remote (monitor 1) is at least 3m from any magnetic item.The monitor 2 is in the control room, far from any other devices with magnet.Bwi representative sent the data from ngen generator to technical services, and it stated that rf was not delivered when the physician released the pedal.However, carto and monitor showed the contrary and this is still under investigation.Stuck foot pedal is mdr-reportable.

Manufacturer Narrative

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 4.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 15-nov-2022, the product investigation was completed.It was reported that an unknown patient underwent atrial fibrillation (afib) ablation procedure with an ngen rf generator, worldwide configuration, foot pedal was stuck.It was reported that during the first ablation in qdot mode / 40watt after 15 seconds, they had to stop the ablation due to patient issue (not related to biosense product).They released the foot pedal but could still hear the audible noise of the ablation and the graph viewer/ablation mode was still red.They tried to stop manually but it didn't work.They had to turn off to power supply to stop the ablation.The caller think it could be a software issue as when the data showed that the ablation stopped when they released the pedal (the data have been uploaded and are available if needed).They restarted the ngen only and everything was working fine after that.Procedure completed without patient consequences, the procedure was delayed 5 minutes.Device evaluation details: remote support confirmed that no failure was found.Device history record evaluation was performed for the finished device number 22190025fg, and no internal actions related to the reported condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: NGEN RF GENERATOR
• Type of Device: CATHETER, ELECTRODE RECORDING
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15569636
• MDR Text Key: 302244373
• Report Number: 2029046-2022-02459
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 12/12/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: D138401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/10/2022
• Supplement Dates Manufacturer Received: 11/15/2022
• Supplement Dates FDA Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; CS CATHETER; NGEN PUMP; PENTARAY NAV CATHETER; QDOT MICRO