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

Model Number M-4800-01

Device Problems Issue With Displayed Error Message (2967); Positioning Problem (3009)

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

Event Date 05/18/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Event Description

It was reported that a map shift occurred on the carto 3 system during mapping phase of an atrial fibrillation procedure.After access across the septum was lost, the physician did not feel comfortable proceeding due to the map shift and aborted procedure.No error messages appeared, no patient movement was detected, and no cardioversion had taken place prior to the map shift.The approximate difference in catheter location before and after map shift was at least 26.6 mm.The patient was under general anesthesia for at least six hours.The patient did not require extended hospitalization due to a medical condition caused by procedure cancellation.This is mdr reportable as map shifts without error message could be potentially caused by a system malfunction and pose a potential risk to patient.

Manufacturer Narrative

Due to the august 2015 fda maintenance where the 3500a codes were updated, the 3500a codes (evaluation codes) will be added until the biosense webster system is also updated.Therefore the following codes apply: (b)(4).It was reported that there was a map shift.Caller reported that there was no patient movement and no error message was displayed.Caller also reported that they lost transseptal and aborted the case.No active troubleshooting could be performed.Follow up with local fse was requested.Fse arrived on site for the system check.Full system test was performed and no problems were found with the system.System is ready for use.The history of customer complaints associated with carto 3 system # (b)(4) was reviewed.1 out of (b)(4) additional reported complaints may be related to the reported issue.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 20667 17; IS 2066717
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5729414
• MDR Text Key: 48510328
• Report Number: 3008203003-2016-00024
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1