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

Model Number M-4800-01

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2014

Event Type  malfunction  

Event Description

During a paroxysmal atrial fribrilation procedure, it was reported that the 12-lead ecg¿s disappeared on both carto® 3 system and ep recording system prior to catheter insertion, an error ¿1201¿ was present on carto 3.The bwi representative exchanged ecg electrodes on the patient without resolution.It was then exchanged the ecg cable from patient interface unit (piu) to patient and the ecg¿s returned, the error was cleared out.The procedure was completed successfully with no patient consequences.On (b)(6), received additional information requested from bwi representative stating that signals were lost on all ecg leads.No catheters were up for intracardiac signals.The loss of signal occurred on both systems at the same time.As per the additional information, the physician was not able to view any signal.Therefore, this complaint became reportable.

Manufacturer Narrative

(b)(4).During a paroxysmal atrial fibrilation procedure, it was reported that the 12-lead ecg¿s disappeared on both carto® 3 system and ep recording system prior to catheter insertion, an error ¿1201¿ was present on carto 3.The bwi representative exchanged ecg electrodes on the patient without resolution.It was then exchanged the ecg cable from patient interface unit (piu) to patient and the ecg¿s returned, the error was cleared out.The procedure was completed successfully with no patient consequences.The replacement body surface ecg cable was sent to the account.The field service engineer (fse) communicated with the bwi representative, that the account received the bs ecg cable.The issue was resolved.The system is operational.The dhr associated with carto 3 # 11929 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: 3625653
• MDR Text Key: 4133853
• Report Number: 3008203003-2014-00009
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2014

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
• Initial Date Manufacturer Received: 01/22/2014
• Initial Date FDA Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1