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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Heart Block (4444)

Event Date 05/10/2023

Event Type  Injury  

Manufacturer Narrative

Biosense webster manufacturer's reference number (b)(4) has 2 reports.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 that a patient underwent an svt ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a heart block and a cardiac tamponade requiring a pericardiocentesis.It was reported that the patient suffered a pericardial effusion.The anesthesiologist stated that the pressure was a little weird, while the ep physician was in the process of a transseptal puncture, and recommended checking for effusion.The ep (electrophysiology) physician checked via ice (intracardiac echocardiography) using a soundstar catheter and confirmed there was a pericardial effusion present on the right anterior.The medical team stated that no ablation had been performed up to this point.A pericardiocentesis is being performed at this moment.The ep (electrophysiology) physician decided to continue the procedure and monitor the effusion.The physician reverted their transseptal attempt and decided to ablate the slow pathway.They also stated that the physician had been struggling for about 8-15 minutes with the transseptal until they noticed that the fluoroscopy was in a cranial tilt.They stated that they verbalized to the physician that there was a change in map shift based on the anatomy post-transseptal attempt.They verbalized to the ep (electrophysiology) physician and staff when they went back to performing the slow pathway ablation.They also stated that about this time, anesthesia stated that pressures were not getting better.The ep physician requested an external transthoracic echo to visualize the effusion and continued with the slow pathway ablation.The jnj company representative stated that "for the majority of the ablations, the active map was set to the old map, because the fam of the new map was further inside, compared to the previous map.Such as that when left-clicking on the new map it would click on the transparent map".They confirmed that they were not using the old his cloud map, they created a new his cloud map and that is what they were using to refer to ablate.They also stated that the his points did not match the anatomy and the coronary sinus catheter was protruding out of its fam.They remapped and then created a new map but still had the old map in high transparency to show the difference in anatomy.The jnj company representative stated that the patient had a heart block during the procedure, that was not present pre-procedure.While utilizing the new his cloud, the physician ablated, the clinical account specialist stated that they called junctions and then sinus, and a few seconds later the physician noticed a heart block and ep staff came off of ablation.When reviewing the timeline of ablations, no first-degree was present indicating any warning within one beat of when ablation was stopped.The ep physician then paced from the ventricle.The caller also confirmed that the ablation location that the physician selected was based on the new his cloud map and the visitags were not intersecting with the new his cloud.They confirmed that there were no errors/messages observed indicating that there was a map shift.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.

Manufacturer Narrative

On 6-jun-2023, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an svt ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a heart block and a cardiac tamponade requiring a pericardiocentesis.It was reported that the patient suffered a pericardial effusion.The anesthesiologist stated that the pressure was a little weird, while the ep physician was in the process of a transseptal puncture, and recommended checking for effusion.The ep (electrophysiology) physician checked via ice (intracardiac echocardiography) using a soundstar catheter and confirmed there was a pericardial effusion present on the right anterior.The medical team stated that no ablation had been performed up to this point.A pericardiocentesis is being performed at this moment.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 31013063l and no internal actions related to the complaint were found during the review.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.That during the operation, there was problem with connector of the device or cable.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: 17059884
• MDR Text Key: 316584363
• Report Number: 2029046-2023-01225
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 31013063L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2023
• 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: AGILIS SHEATH.; BWI QUAD CATHETER.; DECANAV CATHETER.; OCTARAY CATHERER.; THERMOCOOL SMARTTOUCH.
• Patient Outcome(s): Life Threatening; Required Intervention