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

Model Number D134801

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Stroke/CVA (1770)

Event Date 10/08/2019

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 cannot be conducted because no lot number was provided by the customer.(b)(6), manufacturer¿s ref # (b)(4).

Event Description

It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter which had a thrombus formed on the catheter and the patient suffered cerebrovascular accident (cva).After the procedure, when the ablation catheter was removed, a thrombus was found attached to the tip of the thermocool® smart touch® sf bi-directional navigation catheter.The next day in the morning, cerebral infarction was suspected, and the patient was transported to the neurosurgery department of another hospital.It was believed that a thrombus may have spread to the cerebellum.The physician commented that there was an impression that it was difficult to catch the electrical potential on the ablation catheter during left pulmonary vein ablation.The patient had a defragmented myocardium, so it is possible that it was due to original damage.Multiple attempts have been made to gain clarification on this event with no response.Should any new information be obtained it will be assessed and processed accordingly.In conclusion, cva occurred after afib ablation in which thrombus formed on the catheter.While thrombus embolization can lead to cva no bwi device deficiencies nor workflow deviations (e.G.Improper temperature reading, inadequate irrigation, compromised device integrity) were identified that could account for thrombus formation.The customer¿s reported issue of partial ecg loss (difficult to catch the electrical potential) is not considered to be mdr reportable since the risk to the patient is low.This event has been assessed as mdr reportable for the malfunction of ¿thrombus formation¿ and the adverse event of ¿cerebrovascular accident (cva).¿.

Manufacturer Narrative

On (b)(6)2019 , biosense webster inc.(bwi) received additional information which indicated the events occurred post use of bwi products.Medical intervention included a thrombolytic therapy and the physician commented that the patient needs rehabilitation.No error messages were reported.A smartablate generator was in use during the procedure.It was also confirmed that the patient was male.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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: 9269786
• MDR Text Key: 167323896
• Report Number: 2029046-2019-03840
• 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: 10/08/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 11/02/2019
• Supplement Dates Manufacturer Received: 12/25/2019
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening