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

Model Number M-4800-01

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2014

Event Type  malfunction  

Event Description

During a procedure, it was reported that during ablation the ecg signals were lost.After a brief time, all intracardiac signals disappeared on carto 3 and recording system.Connecting the catheters directly to the recording system diminish the issue.On carto 3 displayed an ¿ecg limb disconnection¿ message.The ecg cables were changed but the problem persisted.The procedure was completed conventionally without any patient consequences.On (b)(4), received additional information requested from bwi representative stating that the loss of signals was on all channels, including the 12 leads of body surface and all intracardiac recordings, on both carto and recording system at the same time.Due to this additional information received, this complaint became reportable.Awareness date changed from (b)(6) 2014.

Manufacturer Narrative

The investigation is still in progress.(b)(4).

Manufacturer Narrative

Manufacturer's reference (b)(4) during a procedure, it was reported that during ablation the ecg signals were lost.After a brief time, all intracardiac signals disappeared on carto 3 and recording system.Connecting the catheters directly to the recording system diminish the issue.On carto 3 displayed an ¿ecg limb disconnection¿ message.The ecg cables were changed but the problem persisted.The procedure was completed conventionally without any patient consequences.On (b)(6), received additional information requested from bwi representative stating that the loss of signals was on all channels, including the 12 leads of body surface and all intracardiac recordings, on both carto and recording system at the same time.The field service engineer reported that the issue was solved by changing the ablation adapter cable which was already on site.System is ready for use.The device history records (dhr) associated with carto 3 # 11932 was reviewed and there were not any discrepancies noted.The system met all specifications upon its release.The customer complaint was confirmed.

• 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: 3675800
• MDR Text Key: 4304003
• Report Number: 3008203003-2014-00018
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K090017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2014

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: 02/13/2014
• Initial Date FDA Received: 03/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1