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 Stroke/CVA (1770)

Event Date 11/15/2019

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.(b)(6).Manufacturing record evaluation (mre) cannot be conducted because 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).

Event Description

It was reported that a patient underwent an ischemic ventricular tachycardia ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and suffered a cerebrovascular accident.On (b)(6) 2019, the patient underwent a successful procedure and at the end, the ventricular tachycardia was non-inducible.However, four days post procedure, the patient suffered a stroke.The patient was then hospitalized in the neurology department.No intervention was needed.The patient¿s condition worsened as the patient was paralyzed on the left side and had a general confused condition.Physician¿s opinion on the cause of the event is that it was patient condition related.Dashboard, vector and visitag force visualization features are used during the procedure.Visitag time module parameters force and average color options were used.

• 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: 9501027
• MDR Text Key: 185733969
• Report Number: 2029046-2019-04044
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2019

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/20/2019
• 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): Hospitalization; Life Threatening