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

Catalog Number D134805

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

Patient Problems Death (1802); Ventricular Tachycardia (2132)

Event Date 05/10/2019

Event Type  Death  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device 30185402l number, and no internal action was found during the review.Manufacturer¿s ref # (b)(4).

Event Description

It was reported that a male patient underwent an ischemic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered ventricular tachycardia (vt) and death.Towards the end of the procedure, the patient condition began to decline and went into vt.The patient was shocked, and the heart rhythm was restored; however, his condition continued to decline, and the patient expired.Physician¿s opinion regarding the cause of the death is that it was due to patient¿s low ejection fraction (ef) of 30 % which was related to a preexisting condition.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.

• 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
• 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: 8659021
• MDR Text Key: 146674734
• Report Number: 2029046-2019-03196
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30185402L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2019
• 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): Death; Required Intervention