MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) NAVISTAR® THERMOCOOL®; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1197-16-S

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

Patient Problems Death (1802); Myocardial Infarction (1969); Cardiogenic Shock (2262)

Event Date 01/10/2017

Event Type  Death  

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.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Since the lot number is unknown, the full udi number can not be provided.Concomitant medical products: carto 3 system v6; model #: m-4800-01; serial #: (b)(4).Ep - shuttle rf generator system - 100w; model #: 39d-76x; serial #: (b)(4).Coolflow pump; model #: m-5491-01; serial #: (b)(4).(b)(4).

Event Description

It was reported that a (b)(6) male patient underwent an ablation procedure for ventricular tachycardia with a navistar thermocool catheter and pentaray catheter and suffered an acute myocardial infarction (requiring a left anterior descending coronary artery stent), cardiogenic shock (requiring extracorporeal membrane oxygenation and surgical intervention of impella left ventricular assist device) and the patient expired.During the procedure, the left ventricle was mapped with the pentaray catheter.Navistar thermocool catheter was connected, but not in the chamber.Ventricular tachycardia was successfully induced via pacing from the right ventricle.Cardioversion failed to convert the arrhythmia and the patient decompensated and required resuscitation.Patient was transferred to the intensive care unit.Patient required extended hospitalization as a result of the adverse event.Patient remained in the intensive care unit at the time of complaint update.Patient outcome was unchanged.It was noted that the adverse events were not related to biosense webster, inc.Products.Physician¿s opinion regarding the cause of the adverse events is that they were patient condition related and not related to the carto 3 system.Additional information was received on january 26, 2016 that the patient expired.We are attempting to obtain clarification.However, no further information has been made available.Since this adverse event resulted in the patient's death, it is to be considered mdr reportable.

Manufacturer Narrative

Additional information received on february 8, 2017 stated that the physician¿s opinion regarding the cause of death is that it was related to the patient¿s condition after cardiogenic shock.(b)(4).

• Brand Name: NAVISTAR® THERMOCOOL®
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6294862
• MDR Text Key: 66317399
• Report Number: 9673241-2017-00079
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1197-16-S
• Device Catalogue Number: NI75TCDH
• Device Lot Number: UNKNOWN_D-1197-16-S JRZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: No
• 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; Hospitalization; Required Intervention
• Patient Age: 77 YR