MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	D133603
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); No Code Available (3191)
Date of Event	02/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The device history record (dhr) for the lot number 17733071m has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Concomitant products: carto 3 system, us catalog #: fg540000, serial #: (b)(4).Pentaray catheter, us catalog #: d128207, lot #: 17772304l.Soundstar eco catheter, us catalog #: unknown, lot #: unknown.Non-biosense webster, inc.: impella left ventricular assist device (lvad).(b)(4).
Event or Problem Description
It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure for atrial fibrillation with a thermocool® smart touch¿ electrophysiology catheter and suffered a cardiac arrest requiring chest compressions and a surgical intervention (impella left ventricular assist device).Post-procedure, premature ventricular contractions (pvcs) triggered non-sustained ventricular tachycardia (vt) and subsequently sustained vt.It was noticed on the ekg.Chest compressions were initiated and an impella left ventricular assist device was inserted.Patient was reported to be in stable condition.There is no information about the hospitalization.The physician did not provide a causality opinion for the cause of this adverse event.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since this adverse event required medical/surgical intervention or prolonged hospitalization to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.
Additional Manufacturer Narrative
Additional clarification was received on the event on march 19, 2018.The patient was a (b)(6) year-old female weighing less than 100 pounds.While using biosense webster, inc.Products, premature ventricular contractions (pvcs) triggered a non-sustained ventricular tachycardia (vt) and subsequently a sustained vt.Chest compressions were initiated and an impella left ventricular assist device (lvad) was implanted.Patient was reported to be in stable condition.Patient required extended hospitalization as a result of the adverse event, as she remained intubated and hemodynamic stability was being maintained via the impella lvad.It was noted that the patient was responsive, quickly extubated, and the impella lvad was explanted shortly thereafter.Patient quickly and fully recovered.Medical history includes cardiomyopathy, premature ventricular contractions (pvcs), and a biventricular device (unspecified).Physician¿s opinion regarding the cause of the adverse event is that it was related to the patient¿s condition, specifically, the underlying cardiomyopathy and high-burden pvcs.Per the additional information received, added information to patient age at the time of event, age unit, sex, medical history/preexisting condition and is hospitalization initial/prolonged.Manufacturer's ref.No: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7325851
• Report Number: 2029046-2018-01291
• Device Sequence Number: 1455998
• Product Code: LPB
• UDI-Device Identifier: 10846835009019
• UDI-Public: 10846835009019
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2018
• Device Catalogue Number: D133603
• Device Lot Number: 17733071M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 75 YR