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

Catalog Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 03/12/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation ablation with a thermocool® smart touch® sf bi-directional navigation catheter and during the ablation phase, the patient experienced cardiac tamponade that required pericardiocentesis.After pvi (pulmonary vein isolation), svci (superior vena cava isolation), and 2 ablations of cti (cavotricuspid isthmus), it was confirmed that the patient¿s blood pressure decreased.The pericardial effusion was confirmed by fluoroscopy and intracardiac echocardiography.The rv (right ventricle) electrode catheter that was wiggled and bent on the fluoroscopy.The physician's opinion on the adverse event was the procedure as the issue may have been caused by the rv catheter (other company's product) placed in the right ventricle.The rv catheter was tortuously bent on the fluoroscopy, and it was suggested that the catheter tip was overloaded.However, ablation was performed prior to noting the pericardial effusion.Transseptal puncture was performed with rf needle.No error messages were observed on biosense webster equipment during the procedure.A bent shaft was found on the competitor¿s rv catheter.Pericardial drainage was performed.After that, it was confirmed that the volume of the pericardial effusion had decreased by fluoroscopic imaging and intracardiac echocardiography and blood pressure restored.The procedure was completed.Atrial septal puncture was performed with a rf (radiofrequency) needle.Ablation was performed before the pericardial effusion or tamponade was confirmed.Steam pop was not confirmed.No abnormalities observed prior to use of the product.Patient improved and fully recovered.

Manufacturer Narrative

E1 initial reporter phone: (b)(6).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

On 3-may-2024, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an atrial fibrillation ablation with a thermocool® smart touch® sf bi-directional navigation catheter and during the ablation phase, the patient experienced cardiac tamponade that required pericardiocentesis.After pvi (pulmonary vein isolation), svci (superior vena cava isolation), and 2 ablations of cti (cavotricuspid isthmus), it was confirmed that the patient¿s blood pressure decreased.The pericardial effusion was confirmed by fluoroscopy and intracardiac echocardiography.The rv (right ventricle) electrode catheter that was wiggled and bent on the fluoroscopy.The physician's opinion on the adverse event was the procedure as the issue may have been caused by the rv catheter (other company's product) placed in the right ventricle.The rv catheter was tortuously bent on the fluoroscopy, and it was suggested that the catheter tip was overloaded.However, ablation was performed prior to noting the pericardial effusion.Transseptal puncture was performed with rf needle.No error messages were observed on biosense webster equipment during the procedure.A bent shaft was found on the competitor¿s rv catheter.Pericardial drainage was performed.After that, it was confirmed that the volume of the pericardial effusion had decreased by fluoroscopic imaging and intracardiac echocardiography and blood pressure restored.The procedure was completed.Device evaluation details: 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 (b)(6), and no internal action was found during the review.No malfunction was observed during the product analysis.The potential 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 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 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: 19062408
• MDR Text Key: 339674220
• Report Number: 2029046-2024-01158
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134801
• Device Lot Number: 31215086L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2023
• 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: LASSO NAV 2515,22P SPLITHANDLE; PENTARAY NAV ECO 7FR, D, 2-6-2; SOUNDSTAR ECO SMS 8F CATHETER; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR; UNK_SMARTABLATE PUMP; UNK_SMARTABLATE PUMP TUBING; UNK_TRANSEPTAL NEEDLE
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 74 KG