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

Catalog Number D133602

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

Patient Problem Cardiac Tamponade (2226)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.A manufacturing record evaluation was performed for the finished device with lot number 30205761m, and no internal actions related to the reported complaint condition were identified.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a male patient underwent a right ventricular outflow tract (rvot) and premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and suffered a cardiac tamponade requiring pericardiocentesis.During the ablation phase, the origin of pvc was detected in the rvot and ablated with thermocool® smart touch¿ electrophysiology catheter (power control mode 35w).Post use of biosense webster products, a cardiac tamponade was detected and pericardiocentesis was performed.After that the patient was stable.Procedure was successfully completed.The patient has fully recovered.Physician¿s opinion on the cause of the event is that it was procedure related.No transseptal puncture was performed.There was no evidence of steam pop.Flow setting during the event was 30ml/min for greater than 30w.Graph, dashboard, vector and visitag force visualization features were used during the procedure.Visitag parameters time, force greater than 3g 25% and time color option.

• 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9399497
• MDR Text Key: 176879433
• Report Number: 2029046-2019-03945
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Other
• Type of Report: Initial
• Report Date: 11/06/2019

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 Catalogue Number: D133602
• Device Lot Number: 30205761M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 12/02/2019
• 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): Life Threatening; Required Intervention