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

Model Number M-4800-01

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 10/27/2015

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.Concomitant products: ez steer thermocool sf nav catheter (model# d-1313-04-s, lot# 17271444l).C3 interface cable ¿ therapeutic (model# d-1286-03-s lot# 105039.(b)(4).

Event Description

It was reported that a patient underwent a right sided atrial flutter procedure with a carto 3 system and two lasso 2515 nav eco variable catheters a procedure cancellation occurred.During the procedure, the lasso catheter displayed a magnetic sensor error.The catheter was changed and the second lasso catheter loop would not display therefore the catheter could not be used for fast anatomical mapping.Error 371 "mapping electrodes not available" was seen.More than 30 minutes of troubleshooting was done, including cable and catheter changes, moving the lasso from 20a to 20b, rebooting the piu and the workstation, using a default template, starting a new study and re-initializing.An error 370 "cannot acquire points with mapping catheter" was also displayed.The issue resolved with a piu reboot.The right sided atrial flutter was completed however the atrial fibrillation (afib) portion of the procedure was aborted due to the system issues.Upon request additional information was received on the event.None of the catheters or cables used were reprocessed.A transseptal puncture was performed and the patient was under general anesthesia.The piu was rebooted 5 or 6 times to clear the error.The afib portion was aborted and they were only able to treat the atrial flutter because the physician no longer trusted the carto 3 system.This event is indicative of a reportable event because the patient was under general anesthesia in combined with a transseptal puncture and because the physician no longer trusted the carto 3 system.The carto 3 system is the suspected device of the procedure cancellation in conjunction with the sensor error and bad sensor of the lasso catheter.Therefore both lasso catheters will also be reported separately.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a right sided atrial flutter procedure with a carto 3 system and two lasso® 2515 nav eco variable catheters a procedure cancellation occurred because the physician no longer trusted the carto 3 system.Based on the bwi representatives report, the reboot of the piu resolved the issue.Field service engineer (fse) went on-site to evaluate the system.Fse completed full functional test of the system.System passed all tests.Issue was not duplicated.Fse recommended using new catheters and catheter cables as opposed to reprocessed catheters.System is ready for use.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: 5239406
• MDR Text Key: 32033777
• Report Number: 3008203003-2015-00092
• 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: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/27/2015
• Initial Date FDA Received: 11/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1