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

Catalog Number D134801

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

Patient Problems Heart Failure (2206); Cardiac Tamponade (2226)

Event Date 05/20/2019

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 30165875l number, and no internal action was found during the review.(b)(6).Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure for atrial tachycardia (at) with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade (requiring pericardiocentesis) and heart failure.The case started with the ablation of atrial tachycardia.At stopped and pulmonary vein isolation (pvi) was then performed.Left pulmonary vein (lpv) ablation started and the isolation of left inferior pulmonary vein (lipv) could not be completed as cardiac tamponade was confirmed by echo.Pericardiocentesis was performed simultaneously to remove an unspecified amount of fluid.The right pulmonary vein (rpv) anterior wall was ablated to connect the left atrial anterior line that was ablated during the at procedure.There¿s no information regarding extended hospitalization or physician causality opinion.The patient was reported in a state of heart failure.No biosense webster, inc.Product malfunctions were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

Additional information was received on june 25, 2019 and it was reported that the patient's condition worsened.The physician¿s opinion regarding the cause of the adverse event is that it was patient condition related.It was also reported that the gender of the patient was a male, therefore, sex, was populated with m.Manufacturer's reference # (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: 8689428
• MDR Text Key: 147732419
• Report Number: 2029046-2019-03255
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2020
• Device Catalogue Number: D134801
• Device Lot Number: 30165875L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention