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

Model Number D134804

Device Problems Signal Artifact/Noise (1036); High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/17/2020

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 female patient underwent cardiac ablation procedure for atrial flutter (afl) with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.It was reported that a steam pop and subsequent pericardial effusion occurred during a right atrial flutter ablation.While ablating on the cavotricuspid isthmus, the patient had a ridge that required a lot of ablation.The impedance was higher in this area pre-ablation (the caller mentioned this to the physician).When ablation started the impedance decreased gradually until a spike in impedance occurred and ablation was stopped.Then noise occurred on the distal ablation electrogram.The pericardial effusion was diagnosed using transthoracic ultrasound.The patient had a decrease in blood pressure and heart rate.A pericardiocentesis was performed removing 220ml of blood.The patient stabilized.There was no report of extended hospitalization.The event occurred during use of biosense webster (bwi) products during ablation phase.The physician¿s opinion is that the cause of the vent was patient condition/anatomy requiring extra ablation to achieve block.The physician did not indicate that bwi products contributed to the patient complication.Transeptal puncture was not performed.The ablation power was 30 watts, irrigation flow rate of 8 ml/min.The noted temperature was 26 degrees, 103 impedance, 30 w.Graph, dashboard, vector and visitag were used for force visualization.Visitag stability settings were 3mm for 3sec, 3g of force 25 % of the time, tag index as color option.The system did not continue to deliver energy above impedance cut-off value.The noise appeared only on intracardiac distal (electrode 1-2) of the ablation catheter on both carto and the recording system.Multiple ecg channels were available to the physician during the noise.The last spike in the impedance was most likely due to a steam pop.Steam pop is not an mdr-reportable issue.High impedance is not an mdr-reportable issue.Noise on selected ecg signals is not an mdr-reportable issue.Since cardiac tamponade may be life-threatening it is 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; 33 technology drive; 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: 11000575
• MDR Text Key: 221276560
• Report Number: 2029046-2020-01828
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2020
• 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; RECORDING SYSTEM; SMARTABLATE GENERATOR
• Patient Outcome(s): Life Threatening; Required Intervention