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

Model Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Tachycardia (1731); Cardiac Tamponade (2226)

Event Date 03/05/2020

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference # (b)(4).

Event Description

It was reported that a female patient (in her 60¿s) underwent a right idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.During the ablation phase, the patient would go into atrial fibrillation (afib) during radio frequency (rf) application.The catheter was pulled back into the right atrium (ra) and the patient was cardioverted.Following the cardioversion, the patient¿s blood pressure dropped.A transthoracic echo (tee) was performed and it was found that the patient had a pericardial effusion.Ablation was performed prior to noting the pericardial effusion.A pericardiocentesis was performed in which 400 cc's of fluid was removed from the pericardial space.The patient was stabilized and was then transferred to the cardiac care unit (ccu) for observation.The patient required pericardiocentesis and remained in the ccu but did not require additional hospital stay.The patient¿s outcome was reported to be fully recovered.In the opinion of the physician, the event was related to the nature of the procedure.Transseptal puncture was not performed.There was no evidence of a steam pop.The irrigation settings were standard for thermocool® smart touch® sf bi-directional navigation catheter.There were no errors observed on any biosense webster inc.Equipment.Force visualization features used were graph, dashboard, vector and visitag.There was no impedance spike or drastic change of catheter location or direction used.The visitag stability settings were 3mm for 3 sec, force over time (fot) 25% for 3 g.The color option used prospectively was force with a custom setting of 3-8g.

Manufacturer Narrative

It was reported that a female patient (in her 60¿s) underwent a right idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.Since no device has been received for analysis, no product investigation can be performed and the customer complaint cannot be confirmed.However, a manufacturing record evaluation was performed, and no internal actions were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference no:(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: 9889346
• MDR Text Key: 191595394
• Report Number: 2029046-2020-00484
• 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
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30320696M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention