MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NGEN RF GENERATOR, US CONFIGURATION; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D138402

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 10/03/2023

Event Type  Injury  

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.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).

Event Description

It was reported that a patient underwent a cardiac ablation with a ngen rf generator, us configuration and the patient experienced a skin burn.The adverse event occurred on 03-oct-2023.The physician was unsure what caused the event but suspected it could be an issue with the indifferent electrode.According to the physician, no intervention was provided.The physician stated that healing had already begun by the time the injury was observed, scar remains.According to the physician, the patient's injury status has improved.The indifferent electrode used for the procedure is called valleylab rem polyhesive adult patient return electrode.The product is made by covidien.The serial and lot number of the product used in the procedure is unknown.The patient contact area and indifferent electrode were properly prepared.The indifferent electrode was placed on the patients lower back, just below the back patches.The indifferent electrode was positioned as close to the patient¿s heart as possible.It was believed that there were no air pockets between the skin and the indifferent electrode and that the entire surface area of the product was in contact with the patient¿s skin.There was no conductive gel present on the indifferent electrode.According to lab staff, no conductive gel is typically used.The indifferent electrode was not moist upon opening the packaging.The indifferent electrode is at least 124 cm2.No error codes were listed on the ngen generator during this procedure.The caller does not believe the patient required extended hospitalization.

Manufacturer Narrative

On 22-mar-2024, bwi received additional information indicating that the ngen rf generator, us configuration was not used in the procedure.The complaint generator was a smartablate¿ system rf generator (us).This event has been reported under importer report number 2029046-2024-50004.No further event details will be submitted under this manufacturer report number.Manufacturer's reference number: (b)(4).

• Brand Name: NGEN RF GENERATOR, US CONFIGURATION
• 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: 18655776
• MDR Text Key: 334720700
• Report Number: 2029046-2024-00407
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• 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: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D138402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2024
• 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
• Treatment: CARTO 3 SYSTEM; COVIDIEN VALLEYLAB POLY ADULT PATIENT RET ELECT; NGEN PUMP, US CONFIGURATION; UNK_SMART TOUCH UNIDIRECTIONAL SF
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 75 KG