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

Model Number M-4800-01

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock (2072)

Event Date 02/13/2014

Event Type  malfunction  

Event Description

During an atrial fibrillation (afib), it was reported patient received electrical shock.The procedure was finished by changing the catheter and the cable without any patient¿s consequences.Additional information was requested however no further information was provided at this time.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Manufacturer ref # (b)(4) are related to the same event.The suspicious system was replaced with another one.The suspicious system was sent to carto manufacturer (htc) and it was stated that the customer complaint not confirmed.The system passed full atp and safety tests.The system passed isolation tests for ecg and bp cards.The system was tested by r&d department.The system was tested with a few types of catheters.Reported problems not reproduced.The catheters that have been used with the system and relevant to complaints were tested too.The catheters found operable.The extension cable was not received in htc so further investigation cannot be performed.Issue was not duplicated.The system sent to subcontractor for repair and upgrade.Since this was a mdr reportable event, an additional dhr review was performed.No anomalies were noted in manufacturing or service.

• 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: 3643564
• MDR Text Key: 4209839
• Report Number: 3008203003-2014-00014
• 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,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

• Date FDA Received: 02/24/2014
• 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: 02/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1