MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Cardiac Perforation (2513)

Event Date 11/30/2023

Event Type  Injury  

Manufacturer Narrative

Biosense webster manufacturer's reference number pc-(b)(6) has 2 reports.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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)(6).

Event Description

It was reported a patient underwent a cardiac ablation procedure and patient experienced cardiac perforation treated with a pericardiocentesis, chest compressions and extended hospitalization.No transseptal puncture performed and no ablation performed.During mapping phase, a perforation of the pericardial sack was found after the patient experienced a drop in blood pressure.The issue was confirmed with ultrasound.The medical intervention provided was a tap of the pericardial sack and chest compression.Patient was in stable condition.It was reported patient's pressure dropped again from possible bleeding from another organ.The patient outcome was reported as improved.Physician's opinion on the cause of the adverse event is the procedure.Correct settings used on devices and no error messages on the equipment during the procedure.It was indicated that both the stsf and optrell devices were used for mapping.As both were utilized and come in direct contact with cardiac tissue, both are suspected to be possible contributors to the event.This report is for the stsf catheter.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL SF
• 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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18405288
• MDR Text Key: 331473923
• Report Number: 2029046-2023-03090
• Device Sequence Number: 1
• Product Code: LPB
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• 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: CARTO 3 SYSTEM WITH VISITAG; SMARTABLATE GENERATOR; SMARTABLATE PUMP; UNK_SOUNDSTAR
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female