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

Model Number M-4800-01

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 09/20/2016

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 ablation procedure for idiopathic ventricular tachycardia with a carto 3 system where it was possible to pace and ablate at the same time.This issue had been previously reported and was apparently resolved, but had since returned.For this case, the pacing leads were connected to the direct stimulator port.The pacing stimulator in use was a ge cardiolab.No pacing was required during ablation; the pacing delivered to the patient was unwanted.The procedure was continued with manual pacing and no reports of patient consequence.Unwanted pacing can lead to disorganization of electrical signals, which could mislead the physician.This creates the potential for serious injury, death or other adverse event.As a result, this event is mdr reportable.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an ablation procedure for idiopathic ventricular tachycardia with a carto 3 system where it was possible to pace and ablate at the same time.A field service engineer (fse) went onsite to investigate the issue.Fse exchanged the echocardiogram and backplane cards.Fse then performed a wet bath test, and the issue could not be duplicated.The fse returned the original boards into system, and it was decided to replace the suspected patient interface unit/location pad (piu+lp) kit and to send the suspect device to htc (the device manufacturer) for further investigation.Fse replaced the customer¿s piu+lp with a new kit and completed all required acceptance tests with success.The system was left functioning correctly and ready for use.The suspect device was investigated by the manufacturer, but no failure was found.Testing of the suspect piu found that it was behaving correctly, and that it was impossible to simultaneously engage the pacing and ablation.The history of customer complaints associated with carto 3 system #29061 was reviewed.1 out of 17 additional reported complaints may be related to the reported issue.A device history record (dhr) review was performed by the manufacturer and no anomalies were noted in the manufacturing or servicing of this equipment.The customer complaint was not confirmed.No failure was found.

• 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: 6031198
• MDR Text Key: 57816693
• Report Number: 3008203003-2016-00033
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• 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: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• 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: 09/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1