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

Model Number M-4800-01

Device Problems Device Displays Incorrect Message (2591); Malposition of Device (2616); Device Operates Differently Than Expected (2913)

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

Event Date 06/12/2015

Event Type  malfunction  

Event Description

It was reported that during an afib - atrial fibrillation procedure, the customer experienced a map shift on the carto system without any error massage.It was stated that the catheter appeared to be in the right atrium when it was actually in the left atrium.The location of the catheter was verified on the ultrasound system.This type of issue is assessed as reportable event.A new map was created and the catheter in the coronary sinus was 2 cm away but on fluoro it was accurate.An error 402 (magnetic distortion)was then being displayed on the carto 3 system, however there was no troubleshooting was done to clear the error since the case was already finished without any patient consequence.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Refer to evaluation summary: (b)(4) it was reported that during an afib - atrial fibrillation procedure, the customer experienced a map shift on the carto system without any error massage.It was stated that the catheter appeared to be in the right atrium when it was actually in the left atrium.The location of the catheter was verified on the ultrasound system.This type of issue is assessed as reportable event.A new map was created and the catheter in the coronary sinus was 2 cm away but on fluoro it was accurate.An error 402 (magnetic distortion)was then being displayed on the carto 3 system, however there was no troubleshooting was done to clear the error since the case was already finished without any patient consequence.Biosense field service engineers (fse) visited the account regarding the issue.Fse could not reproduce any issues that could cause map misalignment.Magnetic tests passed and fse performed sid measurement tests to note proper c-arm, table, and detector placement during carto cases.No issues could be replicated.System passed full functional test.During the acceptance test procedure (atp), fse found a defective chest patch 6 that caused failure of the acl calibration tests.The yellow chest patch cable was replaced and the issue resolved.System is ready for use.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 (ISRAEL) LTD.; 4 hatnufah street; yokneam 2066 717; IS 2066717
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 2066 717; IS 2066717
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4900733
• MDR Text Key: 6539567
• Report Number: 3008203003-2015-00051
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• 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: 06/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1