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

Model Number M-4800-01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 05/15/2014

Event Type  malfunction  

Event Description

It was reported that during an ablation procedure with the use of the carto 3 system, there was a stimulation problem.To resolve the issue, they exchanged the body surface (bs) cable and the stim cable.There was no patient injury reported in this procedure.Upon request, additional information was provided on (b)(6) 2014.Pacing was used to induce arrhythmia.It was impossible to pace through all the patient interface unit ports which included the emergency or direct pacing ports of the carto 3 system.There was no error.All cables were connected as usual.In order to pace, the user had to connect the catheter on the ep bard recording system directly.They tried to stimulate after the ablation, not during.The stimulator being used was the micropace.Pacing on the ep bard recording system was correctly configured.Per the additional information received on (b)(6) 2014 stating that the pacing was not possible with the emergency/direct pacing port, this issue is indicative of a reportable event.Marking (b)(6) 2014 as the awareness date for this report.

Manufacturer Narrative

Investigation still in progress.A supplemental report or device evaluation will be submitted.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that during an ablation procedure with the use of the carto 3 system, there was a stimulation problem.It was impossible to pace through all the patient interface unit ports which included the emergency or direct pacing ports of the carto 3 system.There was no error.All cables were connected as usual.In order to pace, the user had to connect the catheter on the ep bard recording system directly.They tried to stimulate after the ablation, not during.The stimulator being used was the micropace.Pacing on the ep bard recording system was correctly configured.To resolve the issue, they exchanged the body surface (bs) cable and the stim cable.There was no patient injury reported in this procedure.A broken pacing cable caused the issue.The cable was replaced with another one, and as a result, the issue was resolved.Also, the bs ecg cable was replaced as it was broken.However, the broken bs ecg cable was not related to the pacing problem.The history of customer complaints associated with carto 3 system # 11195 was reviewed.Three out of twenty additional reported complaints, may be related to the reported issue.A 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, LTD (HAIFA, ISRAEL); 4 hatnufah st.; yokneam 20692 ; IS 20692
• Manufacturer (Section G): BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL); 4 hatnufah st.; yokneam 2069 2; IS 20692
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3854760
• MDR Text Key: 20106746
• Report Number: 3008203003-2014-00042
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K090017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2014

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: 05/15/2014
• Initial Date FDA Received: 06/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1