MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THMCL SMRTTCH,BI,NAV,TC,D-F,C3; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D132705

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

Patient Problems Stroke/CVA (1770); Transient Ischemic Attack (2109)

Event Date 03/20/2019

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no medical record evaluation (mre) review could be performed.(b)(4).

Event Description

It was reported that a female patient underwent a left sided idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and suffered transient ischemic attack (tia) requiring no interventions.One day post procedure, the patient had a tia (limited left-hand movement).The patient was reported to be in stable condition and was transferred to the coronary cardiac unit (ccu) for observation purposes.No medical/surgical intervention was provided.There¿s no information regarding extended hospitalization and patient¿s outcome.The physician indicated he does not believe the cause of the adverse event is the result of the ablation or related to a product malfunction.Ablation was not performed near a coronary artery.

Manufacturer Narrative

It was reported that a female patient underwent a left sided idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and suffered transient ischemic attack (tia) requiring no interventions.In the initial report, the manufacture address was erroneously reported as 31 technology dr.Irvine, ca 92618.The correct address is 33 technology dr.Irvine , ca 92618.Section d3 of this report has been updated.Manufacture ref no: (b)(4).

Manufacturer Narrative

It was reported that a female patient underwent a left sided idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and suffered transient ischemic attack (tia) requiring no interventions.During an internal review on (b)(6) 2019, the patient event has been reclassified from transient ischemic attack reported in the initial, to cerebrovascular accident.Patient code of this report has been updated.  manufacture ref no: (b)(4).

• Brand Name: THMCL SMRTTCH,BI,NAV,TC,D-F,C3
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology; irvine CA 92618
• MDR Report Key: 8520526
• MDR Text Key: 142194192
• Report Number: 2029046-2019-02996
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D132705
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other