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

Model Number M-4800-01

Device Problems Alarm Not Visible (1022); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).The investigational analysis has been completed.The biosense webster field service representative contacted the account regarding this issue.The biosense webster field service representative explained to the account all the possible cases in which a map shift can happen and the situations that carto can compensate or not.The biosense webster field service representative was informed by the account and physician that this map shift issue was not caused by the carto system and system was used many times after the occurrence, and no issue was reported.The system test was declined by customer.The biosense webster field service representative confirmed that the system is operational.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 patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.Just before starting the ablation phase, a map shift was noticed but the carto 3 system did not recognize it.The map shift was discovered as the catheter with more than 20gr of force was suddenly inside the map previously created.The approximate difference in catheter location before and after the map shift was more than 1cm.No cardioversion was performed prior to the map shift.The patient did not move before detecting the shift.The procedure was completed by guiding the ablation with the use of fluoroscopy with no patient consequence.Such map shifts without an error message could potentially be caused by a system malfunction and there would be a potential risk to the patient.Therefore, this event has been assessed as a reportable malfunction.

• 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: 6050730
• MDR Text Key: 58556959
• Report Number: 3008203003-2016-00035
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-4800-01
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1