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

Model Number M-4800-01

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 05/05/2016

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.The workstation was freezing on every point during the procedure.However, they were still able to corroborate the catheters position by fluoroscopy.Troubleshooting was performed but there was no resolution.There was a delay however, the physician did not consider that the delay may have caused or contributed to a death or a serious injury to the patient.It was also noted that per the ultrasound visualization, the map shifted approximately 2mm when they were past the vein ostium.They had finished ablating at that point.No error message populated for the map shift and it was not known if a cardioversion had been performed prior to the map shift.The procedure continued and there was no patient consequence.The workstation freezing during ablation was assessed as not reportable as the physician had fluoroscopy available to determine the catheters location and the physician did not consider that the delay may have caused or contributed to a death or a serious injury to the patient.The map shift with no error message and no confirmed patient movement was assessed conservatively as a reportable malfunction as there is 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.The workstation was freezing on every point during the procedure.They received a message on boot up that the ram memory had changed.They were initially using cartosound and confidense and they turned off confidense to try to improve performance, without resolution.They had not tried rebooting the workstation.The procedure was almost over.Procedure continued with freezing.A replacement workstation was sent to the account.The biosense webster field representative contacted the biosense webster field service engineer and stated that the workstation was replaced and a procedure was completed successfully without any issues to report.The system is operational.The replaced workstation was sent to the device manufacturer for investigation.The customer complaint was confirmed.The ram memory cards were found defective which caused the reported issue.It was also noted that per the ultrasound visualization, the map shifted approximately 2mm when they were past the vein ostium.It could not be determined whether the map shift was due to patient movement during the cardioversion or the freezing workstation.The biosense webster field service engineer followed up on the issue.The device manufacturer asked to have the study data provided for further investigation.The requested data was not received.It was reported that the study data was removed from the workstation and is no longer available to send to the device manufacturer for analysis as the workstation was replaced due to the hardware failure.Therefore, the root cause of the map shift cannot be determined.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: 5690393
• MDR Text Key: 47329045
• Report Number: 3008203003-2016-00018
• 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: 05/05/2016

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2016
• Initial Date FDA Received: 06/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2016
• 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