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

Model Number M-4800-01

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2016

Event Type  malfunction  

Manufacturer Narrative

The hardware 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 patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a carto 3 system and a map shift occurred.The carto 3 system displayed a "silent map shift" during ablation without any errors, alerts or patient movement.It was confirmed that the position of the his catheter had shifted to the left and lower versus the x-ray system display.The approximate difference was about 10mm.Proper respiratory gating had been performed and had not changed.The case proceeded without patient harm.This event is mdr reportable because map shifts with no errors or patient movements could lead to a potential risk to the patient.

Manufacturer Narrative

(b)(4) it was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a carto 3 system and a map shift occurred.Since this carto 3 system is not covered by warranty, service was declined.Device history record 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 ; 9497893837
• MDR Report Key: 5452427
• MDR Text Key: 39273046
• Report Number: 3008203003-2016-00004
• 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: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1