MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problems High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/28/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a cardiac tamponade requiring a pericardiocentesis and surgical intervention.A pericardial effusion was noticed after the ablation was completed.They stated that they had performed cryo ablation first, then the ablation catheter was inserted into the patient for mapping and 20 ablation lesions were performed prior to noticing the pericardial effusion.They reported that about 2 minutes after the ablation was performed, the patient's blood pressure dropped.The pericardial effusion was confirmed with intracardiac echocardiography (ice).A pericardiocentesis was performed and that she thought 1800 cc's of fluid were removed.The patient was taken to surgery to perform repairs because the patient was still bleeding.The patient was in stable condition when the patient was being taken to surgery.After reviewing the procedure, they found that there were high force readings displayed on the carto 3 system during mapping in the left pulmonary superior vein and appendage area and also the roof of the right superior pulmonary vein.It was believed that the pericardial effusion occurred during mapping or during ablation.The ablation catheter will be returned for analysis.Additional information was received.Packaging was discarded prior to calling in the issue.The adverse event was discovered during use of the ablation catheter.Physician¿s opinion on the cause of this adverse event was that as of (b)(6) 2022, it seemed like he believed it was caused by the procedure.Intervention provided was a pericardiocentesis and patient was taken to surgery.They do not know what specific actions were taken during surgery.Outcome of the adverse event was unknown.Most likely that the patient required extended hospitalization because of the adverse event since they had to go for more extensive surgery.Transseptal puncture was performed.Pressure drop/effusion was observed during ablation.They used their standard template on the generator.Parameters for stability for the visitag module use was (range; time; fot; tag size)¿ 3,3 and size 2.No additional filter used with the visitag.Since the event was life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.The high force issue was assessed as non mdr reportable.The issue was highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event was low.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The investigation was completed on 20-jan-2023.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16031247
• MDR Text Key: 305976327
• Report Number: 2029046-2022-03228
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 01/20/2023
• Supplement Dates FDA Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNKNOWN BRAND GENERATOR; UNK_CARTO 3
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Male