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

Model Number D133601

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/10/2020

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 (mre) cannot be conducted because 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.(b)(4).

Event Description

It was reported that a female patient underwent cardiac ablation procedure for paroxysmal atrial fibrillation with thermocool® smart touch¿ electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis.The patient had a pericardial effusion and tamponade.The event did not happen because of the used catheter and sheath.The sheath and catheter were working properly.The staff used a catheter with contact force to have the best control of the force during the procedure including the force graph.A visible sheath was used so that the physician had the best control and was able to see how they moved the sheath back- and forward.This adverse event was discovered, post use of biosense webster (bwi) products.The physician thinks that it was not a bwi product malfunction.The event required a medical intervention called pericardial puncture.Because of the pericardial puncture it was necessary to extend the hospital stay.The final outcome was not reported.The physician considers procedure as the cause of the event.Dashboard, vector and visitag were used for force visualization.The visitag stability settings were range of 3mm for time 3 sec, force over time 25% of 3g, respiration gating and force time intervel (fti) as prospective color option.Transseptal was performed with an unknown device.The event was discovered post ablation, there was no evidence of steam pop.The irrigation flow was set to 30ml/min.

• Brand Name: THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY 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: 10973118
• MDR Text Key: 220972895
• Report Number: 2029046-2020-01902
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: 10846835008982
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2020

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 Model Number: D133601
• Device Catalogue Number: D133601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/08/2020
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention