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

Catalog Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 01/29/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced cardiac tamponade that required pericardial drainage and prolonged hospitalization.There was a suspected steam pop during right pulmonary vein (rpv), but no significant change in resistance.There was no change in blood pressure afterwards either.During ablation of the left pulmonary vein (lpv) anterior side, a steam pop occurred, followed by a drop in blood pressure and a pericardial effusion.Pericardial drainage was performed.Patient required extended hospitalization.The physician's opinions on the relationship between the event and the product is that there was no problem with bw product.No abnormalities observed prior to or during use of product.Additional event infomration was received indicating the physician's judgment on health hazard is serious.The patient stayed in the intensive care unit (icu).Transseptal puncture was performed with rf needle.Ablation was performed prior to noting pericardial effusion.No error messages observed on biosense webster equipment during the procedure.

Manufacturer Narrative

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.E1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced cardiac tamponade that required pericardial drainage and prolonged hospitalization.There was a suspected steam pop during right pulmonary vein (rpv), but no significant change in resistance.There was no change in blood pressure afterwards either.During ablation of the left pulmonary vein (lpv) anterior side, a steam pop occurred, followed by a drop in blood pressure and a pericardial effusion.Pericardial drainage was performed.Patient required extended hospitalization.Device evaluation details: the device evaluation has been completed.Visual analysis revealed no damage or anomalies on the device.No char, thrombus or clot was observed during the visual inspection.The physician's requested a close examination of the product; then, the device features were reviewed in detail, and no issues were observed during the product investigation.An irrigation test was performed and the device was flushing correctly.No obstructed holes or irrigation issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis, then the issues reported by the customer could not be confirmed.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The physician's opinions on the relationship between the event and the product (comments): no problem with bw product.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 20-mar-2024, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18764604
• MDR Text Key: 336050722
• Report Number: 2029046-2024-00600
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31173542L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2023
• 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: OCTA,LNG,48P,3-3-3-3-3,D-CURVE.; SMARTABLATE GEN. KIT (JAPAN).; UNK RF NEEDLE.; UNKNOWN PUMP.; UNK_CARTO 3.
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 78 YR
• Patient Sex: Male