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

Model Number D134804

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/01/2022

Event Type  Death  

Event Description

It was reported that an unknown male patient underwent a persistent idiopathic ventricular tachycardia (idvt-asc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.A patient died following an idvt ¿ asc ablation procedure.It was reported that a patient death occurred following an idvt ¿ asc ablation procedure.The physician stated that the patient had turned acidotic and that the blood pressure wasn¿t able to be supported and wasn¿t holding.The patient was being monitored at the hospital through the weekend after having a procedure on friday, (b)(6).The medical team believed the patient¿s symptoms were ongoing between saturday, (b)(6), and sunday, (b)(6).Information about an injury and the medical intervention provided was not disclosed by the physician.The patient passed away on sunday, (b)(6).The physician did not believe that the death was due to the ablation procedure.It was noted that they used ice (intracardiac echocardiography) throughout the entire procedure and that there were no indications to lead them to believe that there were any issues with the ablation procedure.The catheter used was an stsf f/j, the lot number is unknown and not available for return.The adverse event occurred after the procedure, so all product was disposed of at the end of the procedure.The physician believes the event was not caused by the procedure.It is unknown what kind of intervention was provided.A stockert gmbh smart ablate system rf generator us (sn # (b)(4)) was used.The physician¿s opinion on what was the cause of death is unknown.Details about the death event is unknown as the event occurred after the procedure.All deaths were bwi fda approved ¿ ce mark devices are involved are reportable.

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the 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.Manufacturer's reference number: (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; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14552819
• MDR Text Key: 293055246
• Report Number: 2029046-2022-01160
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2022
• 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
• Treatment: SMARTABLATE GENERATOR KIT-US
• Patient Outcome(s): Life Threatening; Death
• Patient Sex: Male