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

Model Number M-4800-01

Device Problem Insufficient Information (3190)

Patient Problem Sepsis (2067)

Event Date 04/05/2014

Event Type  Death  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Event Description

During a pulmonary vein isolation (pvi) procedure, the physician isolated all four pulmonary veins and since the patient was in atrial flutter, a roof line was performed.The procedure was finished without patient consequences.Three weeks post-procedure this patient presented to the hospital with epileptic seizures and fever; blood cultures were positive.Cerebral ct scan showed no abnormalities.Thoraco-abdominal ct-scan revealed coagulated blood in stomach.The decision was taken to perform a gastroscopy to identify source of bleeding.During gastroscopy, blood pressure dropped and patient went into cardiac arrest, due to a hemorrhagic stroke.Subsequently, the patient expired.The physician's opinion regarding the causality of this event was procedure related.This event was originally reported under smart touch catheter, report# 9673241-2014-00158.On july 8th 2015, additional information was received.This case was presented during heart rhythm society symposium and the physician showed his use of carto 3 system and visitag module and force time integral.The physician's force time integral target values were 800g.His force time integral values are beyond st.Jude medical recommendations.St.Jude medical recommends force time integral of 400g.The physician's opinion regarding the causality of this event was procedure related.Per carto 3 system ifu: the carto visitagt module provides access to data collected during the application of rf energy.The data does not indicate the effectiveness of rf energy application.Lesion formation depends on many factors that include but are not limited to catheter stability, power, time, and applied force.The carto visitag tm module provides visual display for tracking these parameters.The visitagt" module locations can be colored according to fti, a calculation of force and time.However, it is important to note that the fti value is not a lesion predictor.

Manufacturer Narrative

(b)(4) during a pulmonary vein isolation (pvi) procedure, the physician isolated all four pulmonary veins and since the patient was in atrial flutter, a roof line was performed.The procedure was finished without patient consequences.Three weeks post-procedure this patient presented to the hospital with epileptic seizures and fever; blood cultures were positive.Cerebral ct scan showed no abnormalities.Thoraco-abdominal ct-scan revealed coagulated blood in stomach.The decision was taken to perform a gastroscopy to identify source of bleeding.During gastroscopy, blood pressure dropped and patient went into cardiac arrest, due to a hemorrhagic stroke.Subsequently the patient expired.The physician¿s opinion regarding the causality of this event was procedure related.This event was originally reported under smart touch catheter, report# 9673241-2014-00158 on july 8th 2015, additional information was received.This case was presented during heart rhythm society symposium and the physician showed his use of carto 3 system and visitag module and force time integral.The physician¿s force time integral target values were 800g.His force time integral values are beyond st.Jude medical recommendations.St.Jude medical recommends force time integral of 400g.The physician¿s opinion regarding the causality of this event was procedure related.Per carto 3 system ifu: the carto visitagt module provides access to data collected during the application of rf energy.The data does not indicate the effectiveness of rf energy application.Lesion formation depends on many factors that include but are not limited to catheter stability, power, time, and applied force.The carto visitag tm module provides visual display for tracking these parameters.The visitagt" module locations can be colored according to fti, a calculation of force and time.However, it is important to note that the fti value is not a lesion predictor.The customer did not report any malfunction of the carto system and no service was requested for this device.It was confirmed by the physician that the event was the procedure related but not the carto system related.System is operational.The device history record review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.Management is notified of failure analysis through the monthly trending reports.No significant trends have been identified at this time; therefore no capa activity is required.

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER (ISRAEL) LTD. (OBSOLETE); 4 etgar st po box 2009; tirat hacarmel 39120 ; IS 39120
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD. (OBSOLETE); 4 etgar st po box 2009; tirat hacarmel 39120 ; IS 39120
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4987806
• MDR Text Key: 22409067
• Report Number: 9681484-2015-00001
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 04/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 68 YR