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 Perforation (2513)

Event Date 08/21/2023

Event Type  Injury  

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).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac perforation requiring a pericardiocentesis.During the procedure, they noticed the patient's blood pressure dropped.They stated the physician first utilized the intracardiac echocardiography (ice) catheter to try and confirm the source of the issue, but they were unable.However, upon using a transthoracic echocardiogram (tte) they were able to locate a pericardial effusion.The patient was then provided pericardiocentesis and 1000 ccs were removed from the patient and 370 ccs were put back into the patient's body.At that time the patient was stable, and they were transferred to the intensive care unit for recovery and monitoring.They stated this was part of the real af trial.The vizigo sheath, an octaray catheter, an thermocool® smart touch® sf bi-directional navigation catheter, and a reprocessed sterilmed acunav catheter were used in the procedure.The physician stated that the perforation may have occurred from the thermocool® smart touch® sf bi-directional navigation catheter, but they are not sure.Additional information was received on 28-aug-2023.It was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event was the procedure.Outcome of the adverse event was fully recovered (no residual effects).Patient required extended hospitalization because of the adverse event for two additional days.Transseptal puncture was performed with an abbott brk-1 needle.Prior to noting the adverse event, ablation was performed.No evidence of steam pop.The event occurred during the ablation phase.Correct catheter settings were selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.No error messages observed on biosense webster equipment during the procedure.All force visualization features were used.Visitag module was used, parameters for stability used was 2.5mm, 3sec, 25% over 3g, 3mm.No additional filter used with the visitag.Color options used was tag index surpoint.Additional information was received on 29-aug-2023.Surgery was delayed due to the reported event by 2 hours.Pulmonary vein isolation was completed, cavotricuspid ishmus (cti) ablation was not completed.Noticed drop in blood pressure during mapping phase.Intervention was at ablation phase.

Manufacturer Narrative

The investigation was completed on 01-nov-2023.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 31089718l number, and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac perforation requiring a pericardiocentesis.The bwi product analysis lab received the device for evaluation on 09-nov-2023.The device evaluation was completed on 17-nov-2023.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 batch number, and no internal actions were identified.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 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: 17747549
• MDR Text Key: 323426199
• Report Number: 2029046-2023-02074
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• 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: 31089718L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2023
• 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: 8.5F SHEATH WITH CURVE VIZ SMC.; ABBOTT BRK-1 NEEDLE.; ACUNAV (ACU10135936).; OCTA,STD,48P,2-2-2-2-2,D-CURVE.; SMARTABLATE GENERATOR KIT-US.; UNK PUMP.; UNK_CARTO 3.
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 105 KG