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 Problem Cardiac Tamponade (2226)

Event Date 11/17/2022

Event Type  Injury  

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib)ablation procedure thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis.It was reported by the bwi representative that the physician noticed the patient's pressure dropped abruptly.The ice catheter confirmed the patient had pericardial effusion.A pericardiocentesis was done and 100cc of fluid was removed.The patient was stable when they left the room.The patient did not require surgical repair.The patient is staying overnight in the icu for observation.While the patient was in the procedure room they were able to drain all of the fluid from the pericardium.The drain was left in place in the patient.They spoke with the physician and they reviewed some of the vizi tags and some of the ablations.They had ablated for about 20 minutes when the patient's blood pressure dropped abruptly.They think when they were pulling out from the ivc or re-advancing the ablation catheter through the ivc that maybe it happened then, but he really has no idea.The bwi representative states it is unlikely that any of the left atrial stuff caused the pericardial effusion as the blood appeared to be venous in nature and the physician was unsure of the cause.They used a soundstar, sts catheter, and an octaray catheter, and no sheath was used.The total watts used for ablation was nothing higher than 45 watts.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 and mdr-reportable.

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.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

On 26-may-2023, the product investigation was completed as the complaint device was not returned.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 number lot 30893028l and no internal action 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).

• 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: 15990306
• MDR Text Key: 305584694
• Report Number: 2029046-2022-03135
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

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 Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30893028L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 05/26/2023
• Supplement Dates FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2022
• 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: OCTARAY CATHETER; SOUNDSTAR CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention