MAUDE Adverse Event Report: BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM; SIMILAR DEVICE FG540000, 510K # K042999

Model Number FG-5400-00J

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

Patient Problems Bradycardia (1751); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 06/28/2017

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.Concomitant products: unspecified coronary sinus and right ventricle catheters, fukuda denshi pacing stimulator.Manufacturer's ref.No: (b)(4).Biosense webster manufacturer reference numbers (b)(4) are related to the same incident.

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto 3 system and suffered ventricular tachycardia (requiring intracardiac defibrillation), ventricular fibrillation (requiring external defibrillation and percutaneous cardiopulmonary support), and bradycardia (requiring cardiac massage).During the procedure, after the coronary sinus (cs) catheter was inserted and while planned pacing was being performed from the right ventricular (rv) catheter, the patient went into ventricular tachycardia.Intracardiac defibrillation converted ventricular tachycardia to ventricular fibrillation, as the energy was delivered on the t-wave (during cardiac repolarization).External defibrillation terminated the ventricular fibrillation and converted the patient to sinus bradycardia.Cardiac massage was performed and percutaneous cardiopulmonary support (pcps) was initiated.Patient was transferred to the intensive care unit (icu).There is no information regarding extended hospitalization.Patient outcome is improved.It was noted that the physician indicated that he inadvertently requested intracardiac defibrillation.Physician¿s opinion regarding the cause of the adverse event is that it was related to procedure or patient condition.There is no information regarding spi value, catheter proximity, or catheter zeroing.Carto did not allow pacing and ablating at the same time.Pacing was planned.No unwanted pacing was delivered.This event was previously reported under report #9673241-2017-00581, which was filed against a generic catheter catalog number.However, additional follow up determined that this carto 3 system was the only bwi product in use.As such, it will now be reported with this manufacturer¿s reference number.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto 3 system and suffered ventricular tachycardia (requiring intracardiac defibrillation), ventricular fibrillation (requiring external defibrillation and percutaneous cardiopulmonary support), and bradycardia (requiring cardiac massage).The technical service team offered to inspect the customer¿s device, but service was declined.The history of customer complaints associated with carto 3 system # 50095 was reviewed.There were no additional complaints (out of 15 additional reported complaints) that may be related to the reported issue.A device history record (dhr) review was performed by the manufacturer, and no anomalies were noted in the manufacturing or servicing of this equipment.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint cannot be confirmed.

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: SIMILAR DEVICE FG540000, 510K # K042999
• 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: 6742408
• MDR Text Key: 80990725
• Report Number: 3008203003-2017-00028
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG-5400-00J
• Device Catalogue Number: FG540000J
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention