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

Model Number M-4800-01

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Fever (1858); Pain (1994); Swelling (2091); Cardiac Tamponade (2226); Complaint, Ill-Defined (2331); Sweating (2444); Weight Changes (2607)

Event Date 06/01/2015

Event Type  Injury  

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) are related to the same incident.

Event Description

It was reported that a patient, (b)(6), male, underwent a pulmonary vein isolation (pvi) procedure with a thermocool smarttouch bi-directional navigation catheter and a carto 3 mapping system and suffered a cardiac tamponade, which required a pericardiocentesis.Ten days after the procedure, the patient was diagnosed with a late tamponade.The physician performed a pericardiocentesis on the patient.The patient fully recovered and is clinically asymptomatic.Additional information was received on the event.A transseptal puncture was performed with an unknown needle.Anticoagulation was provided to the patient and maintained at 250-300s during the procedure.After the pvi, the patient suffered from thoracic pain, subfebrility, dyspnea, coughing, fever, sweating, 8kg weight gain with swollen feet, abdomen and orthopnea.The patient did require hospitalization due to the pericardiocentesis.It is unknown when the event occurred but it is thought to have probably occurred during the ablation phase.Settings during the event include: temperature control mode / irrigation flow setting 17-30ml/min / 8f preface sheath was used.The physician's opinion regarding the cause of this adverse event is that this is procedure related as a result of excessive ablation due to the use of visitag.Since the use of visitags, physicians tend to ablate until a certain fti value is reached.This might lead to overshooting.Therefore in taking a conservative approach, this event is also be reported under both the ablation catheter and the carto 3 system.The bwi awareness date for this complaint is 9/23/2015, the date in which a bwi employee was first made aware of this adverse event.

Manufacturer Narrative

(b)(4) it was reported that a patient, 63 year old, male, underwent a pulmonary vein isolation (pvi) procedure with a thermocool® smarttouch® bi-directional navigation catheter and a carto 3 mapping system and suffered a cardiac tamponade, which required a pericardiocentesis.The physician¿s opinion regarding the cause of this adverse event is that this is procedure related as a result of excessive ablation due to the use of visitag.Since the use of visitags, physicians tend to ablate until a certain fti value is reached.This might lead to overshooting.Therefore in taking a conservative approach, this event was also reported under both the ablation catheter and the carto 3 system.Bwi representative informed they are not requesting the system to be checked.The system is ready for use.The history of customer complaints associated with carto 3 system # 10386 was reviewed.There were not any additional complaints that may be related to the reported issue.Device history record review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.An internal corrective action has been opened to address this issue.

• 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 ; 9497893837
• MDR Report Key: 5153752
• MDR Text Key: 28454096
• Report Number: 3008203003-2015-00084
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Type of Report: Followup
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR