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 01/08/2024

Event Type  Injury  

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6) hospital.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.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 ventricular tachycardia ablation with a ngen rf generator, us configuration and the patient experienced skin burns.The patient had a burn from the grounding pad.The burn was about the size of the grounding pad and the skin was withered away to the side or pushed over to the side and was white.The grounding pad that was used was the one that is always used and recommended for their cases.It was discovered after the case when they were turning the patient to put them on the stretcher and took the grounding pad off.No errors were observed or anything that said bad contact.Caller shared that he saw the nurse put the grounding pad on the lower back as she normally does and there was definitely well made contact on it.They were able to ablate throughout the whole case so was not sure what may have caused it.Caller was not aware of what medical intervention was provided but that the patient was stable.

• 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: 18619499
• MDR Text Key: 334255517
• Report Number: 2029046-2024-00333
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835018080
• UDI-Public: 10846835018080
• 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
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• 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
• Date Manufacturer Received: 01/08/2024
• 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; UNK_OPTRELL MAPPING CATHETER; UNK_SMART TOUCH BIDIRECTIONAL SF; WEBSTER QUAD CATHETER
• Patient Outcome(s): Other