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

Model Number M-4800-01

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problem Discomfort (2330)

Event Date 09/23/2016

Event Type  malfunction  

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.A map shift of approximately 5cm occurred during mapping and no error message populated.The map shift was discovered because of the inconsistency between the fast anatomical map and contact force.There was no patient movement and no cardioversion was performed.The physician had to remap the chamber to continue the procedure.There was an hour and half delay.According to the physician the delay issue could not cause or contribute to any serious injury of the patient.Only discomfort was reported.The procedure was completed with no patient consequence.Additional information has been requested.However, no further information has been made available.The procedure delay was assessed as not reportable as there was no risk to the patient's health status indicated.The patient's discomfort has been assessed as non serious and therefore not reportable as there is no evidence of medical/surgical intervention or prolonged hospitalization.The map shift with no error message has been assessed as a reportable malfunction as such map shifts could potentially be caused by a system malfunction and there is a potential risk to the patient.

Manufacturer Narrative

Additional information was received on this event on (b)(6) 2016.It was reported that the patient was a (b)(6) year male.Patient's weight was 90 kg.The patient¿s diagnosis pre-procedure was ventricular tachychardia.The physician¿s opinion on the cause of the patient¿s reported discomfort was the patient¿s condition.This issue did not require medical or surgical intervention.The patient did not require extended hospitalization.The patient fully recovered.Manufacturer's ref.No: (b)(4) it was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.A map shift of approximately 5cm occurred during mapping and no error message populated.The map shift was discovered because of the inconsistency between the fast anatomical map and contact force.There was no patient movement and no cardioversion was performed.The physician remapped the chamber to continue the procedure.There was an hour and half delay.According to the physician the delay issue could not cause or contribute to any serious injury of the patient.Only discomfort was reported.The procedure was completed with no patient consequence.The full system testing was performed for confidence and preventive maintenance.All carto 3 acceptances testing procedure passed.The biosense webster field service representative confirmed that the carto 3 was operational.It was discovered that the map shift issue was not caused by the carto system.Physicians are instructed on the occurrences that can lead to map shift and that are not notified by the system.The biosense webster field service representative confirmed that the issue was not duplicated in the following system usages.The device history record (dhr) review was performed by the manufacturer and no anomalies 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: 6041678
• MDR Text Key: 57981020
• Report Number: 3008203003-2016-00034
• 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,Followup
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 90