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

Catalog Number UNK_NGEN RF GENERATOR

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Fistula (1862)

Event Type  Injury  

Manufacturer Narrative

Biosense webster manufacturer's reference number (b)(4) has 2 reports.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, the catheter used in this case is currently unknown, therefore no pma details are available.Follow-up was performed and no additional information was provided.Therefore, this file is processed with the ablation catheter information of the smart touch sf.An article/literature was received entitled ¿importance of vigilance in the evaluation of chest pain following atrial fibrillation ablation." no device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.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.Manufacturer¿s reference number: (b)(4).

Event Description

An article/literature was received entitled ¿importance of vigilance in the evaluation of chest pain following atrial fibrillation ablation." pericardial esophageal fistula (pef) is a serious and fatal complication of catheter ablation.Prompt diagnosis and early intervention are important for pef.Here, we present a pef 14 days after radiofrequency ablation for persistent atrial fibrillation (figure 1).Computed tomography indicated the presence of gas in the pericardial and mediastinal cavities (figure 2), but not in the cardiac chambers or brain (figure 3).Emergency thoracoscopic surgery was scheduled and performed 15 hours after symptom onset.The anterior wall of the middle esophagus was congested and partially adhered to the pericardium.The corresponding pericardium between the left superior and inferior pulmonary veins was also congested (figure 4), but without visible lacerations or fistula.The range of esophageal lesions indicated by methylene blue saline increased after injection into a gastrointestinal drainage tube (figure 5).Porcine fibrin glue and a bovine pericardial patch were used to separate lesioned esophagus and pericardium.During 10 months of follow-up, the patient had no esophageal sequelae.

• 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: 17946855
• MDR Text Key: 325795685
• Report Number: 2029046-2023-02331
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NGEN RF GENERATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: CARTO3
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male