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 Encephalopathy (1833); Cardiac Tamponade (2226); No Code Available (3191)

Event Date 12/28/2018

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.The device history record (dhr) for the lot number 30097649l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Concomitant products: carto 3 system (us catalog # unknown, serial # unknown); cs catheter (us catalog # unknown, lot # unknown).(b)(4).Manufacturer¿s ref # (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade (requiring pericardiocentesis and surgical intervention) and hypoxic encephalopathy.Initially, the carto 3 system was not in use.The treatment effect could not be obtained therefore the physician decided to use the carto 3 system.Then, the operation of the cs catheter was not optimum as compared to when the system was not in use; therefore, the usage of the cs catheter was abandoned.The inside of the left atrium was mapped with the thermocool® smart touch® sf bi-directional navigation catheter.After the mapping was finished, the ablation was conducted.A slight change in the body signal (bs) electrocardiogram was observed and the patient¿s blood pressure dropped.Cardiac tamponade was confirmed by intracardiac echo (ice).Pericardiocentesis was performed to remove the fluid from the pericardium; however, the intervention was unsuccessful, and the patient was moved to surgery.Surgical intervention was completed; however, patient¿s consciousness did not return due to a hypoxic encephalopathy.It is unknown at this time if further medical/surgical intervention was required.There¿s no information regarding extended hospitalization or patient¿s outcome.The physician did not relate the causality of the adverse events to the bwi product.

Manufacturer Narrative

On 2/6/2019, additional product information as received.It was clarified that the correct catalog number is d134801.As such, catalog # has been updated from d134805 to d134801.Additionally, unique identifier (udi) has been updated from (b)(4) to (b)(4).Manufacturer¿s ref # (b)(4).

Manufacturer Narrative

On 3/18/2019, additional event information was received.Patient is a 64-year-old, male, weighing 80kg.The patient¿s pre-procedure condition was paroxysmal supraventricular tachycardia (psvt).The physician¿s opinion on the cause of the adverse event is patient condition.Issue occurred during the ablation phase.No error messages were observed on any bwi equipment during the case.The generator was used in power control mode.The serial # of the concomitant carto 3 system is 50082.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: 8258011
• MDR Text Key: 133467751
• Report Number: 2029046-2019-02586
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2019
• Device Catalogue Number: D134801
• Device Lot Number: 30097649L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 80