MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NGEN RF GENERATOR, US CONFIGURATION; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number D138402

Device Problem Failure to Pump (1502)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Note: 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.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 ref.#: (b)(4).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a ngen rf generator, us configuration and there was a high flow rate activation problem.It is reported that on q-mode the ngen rf generator, us configuration will not flow over 4mm.The min setting is at 4 and the max is set at 15.They are getting a temp limiter error.The bwi representative reseated the pump cable and rebooted the ngen pump and the issue did not resolve.The bwi representative then rebooted the ngen and are awaiting for the doctor to scrub in.Then error 215 map: communication with eco cable timed out.The bwi representative was advised to replace the eco cable but they do not have one.It was reseated and they are awaiting for the doctor to attempt another ablation.

Manufacturer Narrative

On 14-mar-2024, additional information was received providing the serial number of the ngen rf generator.Based on the information received, fields d4 serial and d4 unique identifier( udi) have been updated appropriately.Field d4 catalog has been updated from ¿unk_ngen rf generator¿ to ¿d138402¿.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: NGEN RF GENERATOR, US CONFIGURATION
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 18877574
• MDR Text Key: 337551954
• Report Number: 2029046-2024-00793
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835018080
• UDI-Public: 10846835018080
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D138402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; NGEN PUMP, US CONFIGURATION; QDOT MICRO, BI, TC, D-F; THMCL SMTCH SF BID, TC, D-F; THMCL SMTCH SF BID, TC, D-F; TX ECO CABLE