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

Model Number D134805

Device Problems High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/12/2020

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.A manufacturing record evaluation was performed for the finished device 30405034m number, 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.(b)(4).

Event Description

It was reported that a (b)(6) year old female patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.Before the procedure, there was no evidence of effusion.During the ablation phase in the right inferior pulmonary vein (ripv) wall, the physician noticed a drop-in the patient¿s blood pressure.While reviewing lesion information the physician noticed that there had been an impedance spike on 4 consecutive lesions before the drop in blood pressure occurred.Although the incidence of high impedance reported, there¿s no indication that the user selected impedance cut-off value was exceeded.The potential risk to the patient is remote.Cardiac tamponade was confirmed by intracardiac echography (ice), and reminder of the procedure was aborted.Pericardiocentesis was performed to drain 1 lt of fluid from the pericardial space, and the drainage tube was left in place.The patient was sent to the cardiovascular care unit (ccu) and was reported hemodynamically stable.It is unknown if prolonged hospitalization was required.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition related.Transseptal puncture was done with a brk st jude transseptal needle.The force visualization features used included graph, dashboard, vector and visitag.Tag size 3mm and surpoint settings were used as stability parameters.Impedance drop was used as coloring option.The max wattage used was 40 watts, a total of 66lesions were done, the total ablation time was 12 minutes and the total fluid used was 500ml.

Manufacturer Narrative

On (b)(6) 2020, it was reported a smartablate generator was in use during the procedure.The device has been added to section d11.Concomitant med.Products.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 12/8/2020, biosense webster inc.Received additional information which indicated that the noted impedance was of 120 ohms.Impedance cut-off value was not exceeded.The ablation was stopped using the ¿stop¿ button.Default thermocool® smart touch® sf settings were used throughout the procedure.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10974334
• MDR Text Key: 220973370
• Report Number: 2029046-2020-01904
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2020

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 Expiration Date: 07/06/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30405034M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 12/08/2020; 12/30/2020
• Supplement Dates FDA Received: 01/04/2021; 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0055-2018
• Patient Sequence Number: 1
• Treatment: BRK ST JUDE TRANSSEPTAL NEEDLE; SMARTABLATE GENERATOR KIT-US; UNK_ACUNAV; UNK_PENTARAY
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 75 YR