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 11/11/2021

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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 (b)(6) female patient ((b)(6) kgs) underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that the patient suffered a pericardial effusion.The reporter stated "a single transseptal puncture.First, the pentaray was advanced and a voltage map was completed.The pentaray was exchanged for the ablation catheter.Both lacas were completed, the left and right veins were isolated.The physician exchanged for the pentaray.The pentaray fell out of the left atrium when trying to cross the atrium with the ablation and vizigo sheath.The physician chose to look for an effusion.The physician found an effusion via intracardiac echo using the soundstar catheter.A pericardiocentesis was performed with the assistance of another physician.The procedure was canceled at that time.The sheaths were removed.The patient was transferred out of the lab to post-op.The is patient hemodynamically stable at this time.The effusion was discovered/noticed: via ice.The patient was admitted to the intensive care unit.No suspected perforation.It was confirmed with soundstar.Pericardiocentesis was performed with 300-400 ml fluid removed.It is unknown if the tube was left in place.The procedure was abandoned.There was no evidence of an effusion present before the procedure.The max wattage used was 35 watts.The total number of lesions is unknown.The total ablation time was 41 minutes and 4 seconds.Total fluid: 1,005 ml.Other bwi products: ablation catheter, pentaray catheter, vizigo sheath, soundstar catheter, and decanav.This adverse event was discovered during use of bwi products.The physician¿s opinion on the cause of this adverse event is unknown.The outcome of the adverse event is unchanged.A transseptal puncture was performed.Needle product details: baylis.Before noting the pe or ct ablation was performed.There was no evidence of steam pop.The event occurred post ablation.An irrigated catheter was used in the event, the flow setting was 2 on maintenance and 8 below 30 and 15 above 30.No error messages were observed on biosense webster equipment during the procedure.Force visualization features used were: graph, dashboard, vector, visitag.The visitag module was used, the parameters for stability used were 3mm range, time: 3 seconds, fot: 25% over 3 grams, tag size: 3.Additional filter used with the visitag: respiration gated.The color option used prospectively was tax index.Additional information--generator information: smartablate system stockert gmbh, ref: (b)(4), and sn: (b)(4).The correct settings were selected on the generator.The pump was switching from low to high during ablation.The following products were used: pentaray catheter.Cat no:d128208, vizigo sheath medium.Cat no: d138502, decanav catheter.Cat no: r7f282ct, and soundstar ice catheter.Cat no:10439011.Clarification received from the reporter for the statement "the pentaray fell out of the left atrium when trying to cross the atrium with the ablation and vizigo sheath.,¿ states that after the veins were isolated, the doctor wanted to do a post voltage map with the pentaray.During the catheter exchange (ablation out and pentaray in) the vizigo sheath fell out of the left atrium and into the right atrium (this statement was not related to device detachment in the patient).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.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12931972
• MDR Text Key: 281735968
• Report Number: 2029046-2021-02112
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: BAYLIS TRANSSEPTAL NEEDLE; CARTO 3 SYSTEM; DECANAV CATHETER; PENTARAY NAV ECO; SMARTABLATE GENERATOR; SOUNDSTAR ECO CATHETER; VISITAG MODULE
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 91 KG