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

Model Number M-4800-01

Device Problems Circuit Failure (1089); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2014

Event Type  malfunction  

Event Description

It was reported that during an atrial fibrillation (afib) procedure, there was short circuit from location pad and error 17 was appeared in the system.There was 90 minutes the procedure prolonged as a result.The patient was treated; however, with using of fluoro and no 3d mapping system.Only segmental ablation was performed and pulmonary vein isolation (pvi) was not completed.Sinus was achieved and the veins were isolated.The patient was under low grade general anesthesia and the transseptal puncture was performed prior to the case delay.

Manufacturer Narrative

The concomitant product: lasso nav variable eco model# d-1343-01-s.Manufacturer ref # (b)(4).

Manufacturer Narrative

Manufacturer ref # (b)(4).It was reported that during an atrial fibrillation (afib) procedure, there was short circuit from location pad and error 17 was appeared in the system.There was 90 minutes the procedure prolonged as a result.The patient was treated however with using of fluoro and no 3d mapping system.Only segmental ablation was performed and pulmonary vein isolation (pvi) was not completed.Sinus was achieved and the veins were isolated.The patient was under low grade general anesthesia and the transseptal puncture was performed prior to the case delay.The issue was confirmed.The location pad (lp)/mag tx set was replaced.System was tested, all atp tests passed, system is ready for clinical use.The defective parts were sent to the carto manufacturer (htc).It was stated the customer complaint was confirmed.The location pad found failed.Magnetic channel 4 found out of order (high rms errors and low current).The diode u8 found failed.The mag tx card found operable.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.In addition, a corrective action has been opened to address and resolve this issue.

• 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: 3721651
• MDR Text Key: 16224772
• Report Number: 3008203003-2014-00028
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2014
• 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: 03/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1