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

Model Number M-4800-01

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183)

Patient Problems Death (1802); Fistula (1862); Seizures (2063)

Event Date 11/29/2014

Event Type  Death  

Event Description

It was reported that a male patient underwent an atrial fibrillation (a-fib) procedure with a carto 3 system and suffered an esophageal fistula.After the a-fib procedure, the patient presented to the hospital with seizures.An esophageal fistula was confirmed, so the patient underwent surgical repair of the fistula.Later, the patient expired.Based on the facts of the case and the physician¿s assessment, there was reported device malfunction that led to this event.The physician reported issues with visualization & appearance of visitag on the carto screen during ablation.There was no appearance of visitag during ablation at some areas followed by a sudden appearance of multiple points.This issue may have led to inadvertent prolonged ablation in some areas which may have resulted in the patient injury.This event was previously reported to the fda under report # 9673241-2014-00615 for the thermocool catheter.However, additional information received by bwi on (b)(4) 2015, implicates the carto system as a causative device.The carto complaint awareness date has been reset to the date of this new information.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Concomitant products: lasso 2515 nav, lot #unk; cs decapolaire, lot #unk; stockert generator, serial #unk.Thermocool® smarttouch® uni-directional navigation catheter, lot#17079017m.(b)(4).A hardware investigation is pending.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (a-fib) procedure with a carto 3 system and expired.Based on the facts of the case and the physician¿s assessment, there was a reported device malfunction, with visualization & appearance of visitag on the carto screen during ablation, that led to this event.Bwi reviewed the logs and the export file from the case.No system malfunction or errors were found in the logfiles.Visitags were reviewed with v3 and v4 software, all visitags appeared as expected according to the preset.Respiration training and respiration adjustment were used in the case as recommended.At this stage the findings show that visitag behaved as expected during the case and according to the specifications.Bwi proposed a system check to the customer, but the service was declined due to lab availability.The system is operational and is ready for use.A 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 2066 717; IS 2066717
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4524571
• MDR Text Key: 5411948
• Report Number: 3008203003-2015-00008
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K133916
• 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: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 12/04/2014
• Initial Date FDA Received: 02/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death