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 Fibrillation (2130)

Event Date 10/22/2019

Event Type  Death  

Manufacturer Narrative

The product was discarded.Therefore, no product failure analysis can be conducted and device malfunction cannot be confirmed.A manufacturing record evaluation was performed for the finished device and no internal actions were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a (b)(6)-year-old female patient underwent an idiopathic ventricular tachycardia ablation procedure for idiopathic premature ventricular contractions (pvc) with a thermocool® smart touch® sf bi-directional navigation catheter and suffered ventricular fibrillation (vf) and died.During the procedure, mapping was performed, and a single ablation was done which resulted in suppression of the pv, but not total elimination.Pacing was performed which induced ventricular tachycardia (vt).This was able to be pace terminated.A second vt was then induced which degenerated into vf and the patient required defibrillation.A third vt was induced, followed by vf, and then attempts at defibrillation.Patient¿s rhythm would not stabilize.The patient declined rapidly and blood pressure on the arterial line crashed.Cardiopulmonary resuscitation (cpr) and advanced cardiovascular life support were performed.A transcutaneous surface echocardiogram was performed which did not demonstrate any pericardial effusion.Patient anatomy and size, as well as ongoing cpr interfered with imaging.No attempt at pericardiocentesis was made.Despite resuscitative efforts, the patient did not survive.There were no product malfunctions or concerns with error messages during the case.The physician did not express concern about how the product functioned during the case nor afterward.The physician¿s opinion on the cause of the event is that it was procedure related.The physician suspects the cause may have been due to a coronary dissection, but that was not confirmed.To date, no autopsy or medical examination by a medical examiner has been performed.

• 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: 9325626
• MDR Text Key: 166492415
• Report Number: 2029046-2019-03883
• 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: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30258693M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2019
• 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; Life Threatening; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 113