MAUDE Adverse Event Report: BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number M-4800-01

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

Patient Problems Cardiac Arrest (1762); Death (1802); Sepsis (2067); Cardiogenic Shock (2262)

Event Date 01/20/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).The investigational analysis has been completed.According to the additional information from the customer, it was not a carto issue.The physician¿s opinion on the cause of the issue is that it was the patient's condition.There was no reported deficiency with biosense webster, inc.Products or equipments used during the procedure.The customer also declined service when contacted by biosense webster, inc.Field service engineer.System is ready for use.The device history record (dhr) review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.

Event Description

It was reported that a (b)(6) male patient underwent an ablation procedure for persistent atrial fibrillation with a carto 3 system and suffered sepsis, cardiogenic shock (requiring an impella ventricular assist device), cardiac arrest, and death.During the procedure, the patient¿s rapid ventricular rate led to hemodynamic instability.Cardioversion was unsuccessful.Patient required vasopressors for blood pressure support while under sedation.It was noted that the procedure went well.Post-procedure, the patient was not able to be weaned off of vasopressors.Patient developed bacteremia and cardiogenic shock.Impella device was implanted.On post-procedure day 11, the patient suffered a pulseless electrical activity (pea) arrest that led to the patient¿s death.Patient required extended hospitalization as a result of these adverse events.Cardiovascular medical history includes severe non-ischemic cardiomyopathy.Physician¿s opinion regarding the cause of the adverse event is that it was related to the patient¿s condition.Physician¿s opinion regarding the cause of death is that it was related to severe non-ischemic cardiomyopathy that led to cardiogenic shock.There is no autopsy report available.There were no reports of product malfunction.Since these adverse events resulted in the patient¿s death, they are mdr reportable.

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6371950
• MDR Text Key: 68814699
• Report Number: 3008203003-2017-00012
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• 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: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M-4800-01
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 108