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

Model Number M-4800-01

Device Problem High Readings (2459)

Patient Problems Cardiac Arrest (1762); Ventricular Fibrillation (2130)

Event Date 01/13/2017

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: smartablate generator (model# m-4900-107 serial# (b)(4)), smartablate pump (model# m-4900-109 serial# (b)(4)), webster cs catheter (model# unknown lot# unknown).Manufacturer's ref.No: (b)(4).Biosense webster manufacturer's ref.No.'s (b)(4) are related to the same incident.

Event Description

It was reported that a (b)(6) male patient underwent a crista terminalis ablation procedure for right atrial tachycardia with a carto® 3 system and suffered a ventricular fibrillation cardiac arrest requiring cardioversion (defibrillation).During mapping, an unprovoked primary ventricular fibrillation occurred.Cardioversion successfully converted ventricular fibrillation to sinus rhythm.There is no information regarding extended hospitalization.Patient fully recovered with no residual effects.It was noted that the patient has no structural heart disease, normal potassium levels, and no history of antiarrhythmic medications.Electrocardiogram (ecg) revealed normal qt interval.Physician¿s opinion regarding the cause of the adverse event is that it was related to a possible product malfunction of biosense webster inc.(bwi), st.Jude medical, or both.No pacing or radiofrequency energy was being delivered at the time of the unprovoked ventricular fibrillation.It was noted that pacing was routed through the ep med system directly.Webster cs catheter was in the coronary sinus in a stable position and another catheter was in the mid crista terminalis at the time of the event.No noise on intracardiac ecg was observed and no current leakage message was displayed.Atrial electrograms were clear on both the coronary sinus catheter (webster cs) and the crista terminalis catheter (unspecified) at the onset of ventricular fibrillation.It was also noted that the carto displayed high force values.The high force issue is not mdr reportable because the risk to the patient is low.

Manufacturer Narrative

Additional clarification was received on february 15, 2017.The correct event date was (b)(6) 2017.The customer mentioned that there was no error messages they could see in the ventricular fibrillation case.However, the physician mentioned there may be a current leakage message that displayed very quickly in this case but he is not sure.In addition, there was no force issue for this event.The force issue was incorrectly reported with this event and belongs to another complaint.Therefore there was no exchange of the catheters and only one catheter used during this event.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a (b)(6) male patient underwent a crista terminalis ablation procedure for right atrial tachycardia with a carto® 3 system and suffered a ventricular fibrillation cardiac arrest requiring cardioversion (defibrillation).System was fully tested after the unprovoked primary ventricular fibrillation occurred and no failure was found.System is working according to manufacturer's specifications.Device history record review was performed by the manufacturer and no anomalies, which are related to the reported issue, were noted in manufacturing or servicing of this equipment.

• 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: 6334356
• MDR Text Key: 67545901
• Report Number: 3008203003-2017-00007
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: Initial,Followup,Followup
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2017
• 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): Life Threatening; Required Intervention
• Patient Age: 71 YR