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U.S. Department of Health and Human Services

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

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BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
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.
 
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Brand NameCARTO® 3 SYSTEM
Type of DeviceCOMPUTER, 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 Key6371950
MDR Text Key68814699
Report Number3008203003-2017-00012
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
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 Received03/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberM-4800-01
Device Catalogue NumberFG540000
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2017
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 Treatment Data
Date Received: 03/02/2017 Patient Sequence Number: 1
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