MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D133602

Device Problems Insufficient Cooling (1130); Patient Device Interaction Problem (4001)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Asystole (4442)

Event Date 09/09/2022

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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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 male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter.The patient suffered asystole, air embolism and cardiac arrest.Upon ablation there was a high temperature alarm on the generator.The patient went into asystole and on fluoroscopy the heart was at standstill.Pacing was then started in the ventricle and did capture but the heart was still at standstill.Cpr was then started and the patient was given emergency medication.The patient recovered but the bwi representative was not in the room at that time.It was also reported there was no ultrasound image on the carto and us unit.There was also an unknown error.The bwi representative reseated the us cables and catheters.The soundstar catheter and eco-cable were replaced, and that issue resolved but the image was purple.Through troubleshooting it was determined that the cable needs replacement.Then the ablation irrigation bag was dry and a bubble alarm occurred.They flushed the lines and went to low flow.The adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was a bwi product malfunction air embolus from the ablation fluid bag and patient condition stable and recovered.The patient outcome of the adverse was fully recovered (no residual effects).High temperature is not mdr-reportable.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

On 6-oct-2022, additional information was received indicating the physician¿s opinion on the cause of this adverse event was a bwi product malfunction air embolus from the ablation fluid bag.The smartablate¿ system irrigation pump (us) did alarm for bubbles and the bag did not run dry.Additionally, this event will be considered reportable against the ablation catheter and the pump.The pump tubing is connected to the ablation catheter which was ablating in the left atrium/pulmonary veins.There was a high temperature alarm which is possibly when the air embolism occurred.It is highly likely that an air embolism in the left ventricle from the ablation catheter would cause asystole/ cardiac arrest.It is less likely that an air embolism in the right atrium (likely location of the unknown sheath).As such, biosense webster inc.'s reference number (b)(4) has two reports: manufacture report number # for product code d133602 (thermocool® smart touch¿ electrophysiology catheter).Importer report number # 2029046-2022-50011 product code m490008 (smartablate¿ system irrigation pump (us)).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15531384
• MDR Text Key: 301086403
• Report Number: 2029046-2022-02387
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• 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: 10/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D133602
• Device Catalogue Number: D133602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2022
• 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: CARTO 3 SYSTEM; OCTARAY; SMARTABLATE GENERATOR; SMARTABLATE PUMP; SOUNDSTAR CABLE; SOUNDSTAR CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Male