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

Model Number M-4800-01

Device Problems Image Display Error/Artifact (1304); Invalid Sensing (2293); Failure to Align (2522)

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

Event Date 11/09/2016

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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.Near the end of the procedure during ablation, a map shift occurred.No errors were present.There was no cardioversion performed nor patient movement noted prior to the map shift.The significant map shift of approximately 3mm plus was noticed when ablation points began appearing in the middle of the fast anatomical mapping geometry.They made a new left atrium map to continue with the procedure.There were no further issues and no patient consequence.Afterwards, they noted that the defibrillation pad was overlapping one of the c3 back patches.The issue resolved when the patches were placed properly.This event has been assessed as a reportable malfunction as 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.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.Near the end of the procedure during ablation, a map shift occurred.No errors were present.There was no cardioversion performed nor patient movement noted prior to the map shift.The significant map shift of approximately 3mm plus was noticed when ablation points began appearing in the middle of the fast anatomical mapping geometry.They made a new left atrium map to continue with the procedure.There were no further issues and no patient consequence.The biosense webster field service engineer contacted the biosense webster field representative regarding this issue.The biosense webster field representative was covering this procedure.Afterwards, they confirmed that the defibrillation pad was overlapping one of the c3 back patches.Issue resolved when the patches were placed properly.This is a user error issue.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.

• 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: 6146621
• MDR Text Key: 61723611
• Report Number: 3008203003-2016-00040
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• 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: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1