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

Catalog Number D134701

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 03/28/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation ablation with a thermocool® smart touch® sf uni-directional navigation catheter and the patient experienced cardiac tamponade that required pericardiocentesis and prolonged hospitalization.During an atrial fibrillation (afib) case, a pericardial effusion was noticed.There was a drop in blood pressure in the patient.The pericardial effusion was confirmed by the intracardiac echocardiography (ice) catheter.The medical intervention provided was a pericardiocentesis.The patient was reported to be in stable condition and stayed overnight in the intensive care unit (icu).The physician¿s opinion on the cause of the adverse event was that it was procedure related, and not related to or caused by biosense webster inc.(bwi) catheters.Transseptal puncture (tsp) was performed with an abbott brk transseptal needle.One ablation lesion was performed prior to noting the pericardial effusion.There was no evidence of steam pop.During the ablation, the one lesion was done at 30w and the flow rate was at 8ml, regular flow at 2ml.It was suspected that the event occurred when putting catheters up into the right atrium (ra), after access, and before going transseptal.No error messages were observed during the procedure.Patient has fully recovered but required extended hospitalization, patient was kept overnight instead of outpatient for additional monitoring.

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

It was reported that a patient underwent an atrial fibrillation ablation with a thermocool® smart touch® sf uni-directional navigation catheter and the patient experienced cardiac tamponade that required pericardiocentesis and prolonged hospitalization.During an atrial fibrillation (afib) case, a pericardial effusion was noticed.There was a drop in blood pressure in the patient.The pericardial effusion was confirmed by the intracardiac echocardiography (ice) catheter.The medical intervention provided was a pericardiocentesis.The patient was reported to be in stable condition and stayed overnight in the intensive care unit (icu).The physician¿s opinion on the cause of the adverse event was that it was procedure related, and not related to or caused by biosense webster inc.(bwi) catheters.Transseptal puncture (tsp) was performed with an abbott brk transseptal needle.One ablation lesion was performed prior to noting the pericardial effusion.There was no evidence of steam pop.During the ablation, the one lesion was done at 30w and the flow rate was at 8ml, regular flow at 2ml.It was suspected that the event occurred when putting catheters up into the right atrium (ra), after access, and before going transseptal.No error messages were observed during the procedure.Patient has fully recovered but required extended hospitalization, patient was kept overnight instead of outpatient for additional monitoring.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device number lot 31236971l and no internal action related to the complaint was found during the review.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported.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 opinion on the cause of the adverse event is procedure-related, not related to or caused by bwi catheters.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 reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 19159790
• MDR Text Key: 340800623
• Report Number: 2029046-2024-01330
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

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 Catalogue Number: D134701
• Device Lot Number: 31236971L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2024
• 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: ABBOTT BRK TRANSSEPTAL NEEDLE; NGEN GENERATOR; SOUNDSTAR ECO SMS 8F CATHETER; UNK PUMP; UNK_CARTO 3
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 69 KG