MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMARTTOUCH SF CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 02/20/2023

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).Since no device has been received for analysis, 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)(4).

Event Description

It was reported a patient underwent cardiac ablation procedure with a thermocool smarttouch sf catheter and experienced a cardiac puncture that required extended hospitalization.Details of the event are as follows: after the start of the mapping, the patient dropped in blood pressure, felt worse, observed alterations in his ecg.The surgeon suspected a bubble in the sheath or a problem with the patient's stent.A coronary angiography was ordered.End of the ablation procedure for his coronary angiography (transfer of the patient to another operating room).The surgeon did not find anything on this examination.The patient had a ct scan which revealed a puncture in the apex of the left ventricle, which explains his condition on the examination table.Due to a previous surgery, this event does not lead to further complications.His condition is now stationary and good.At the review of the examination, there were a few contact elevations of the ablation catheter at this location, but these were not sustained applications.The catheter never delivered radiofrequency during this procedure.St segment elevation were the noted alterations on the ecg.Reporters states more likely that no air was introduced.The adverse event was discovered during use of the suspected device.Physician¿s opinion on the cause of this adverse event is procedure and patient condition.Intervention provided was coronarography and ct scan.Outcome of the adverse event for the patient has improved.Patient required extended hospitalization to monitor his state.The ablation catheter was used in procedure but no rf was delivered.Force visualization features were used (dashboard, vector).No visitag parameters were used as no ablation was performed.Carto 3 system software version: 7.2.40.250.Generator information.Make, model, serial number: smartablate (b)(4).Pump information.Make, model, serial number: smartablate pump (b)(4).Since the event is 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.

Manufacturer Narrative

On 27-mar-2023, bwi received additional information regarding the event.After the start of mapping, the patient had a drop in blood pressure and he felt less well.A slight change in his ecg was observed indicating the appearance of a septo-apico-lateral and inferior st+ infarction.The ablation procedure was stopped and the patient was transferred to another room for coronary angiography.The doctor found nothing on the coronary angiography.In addition, there was no pericardial effusion on transthoracic ultrasound.Compared to the cardiac ct scan of (b)(6) 2023, the ct scan of (b)(6) 2023 shows the appearance of a probable arterial pseudo-aneurysm of 11 mm opposite the apex of the left ventricle with hemopericare blade in contact.The patient's condition was reported to have stabilized.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 SMARTTOUCH SF 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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16596192
• MDR Text Key: 311827809
• Report Number: 2029046-2023-00613
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

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?: No
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: No
• 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; SMARTABLATE GENERATOR; SMARTABLATE PUMP; VIZIGO SHEATH
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention