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

Model Number M-4800-01

Device Problems Signal Artifact/Noise (1036); Radio Signal Problem (1511)

Patient Problem Tachycardia (2095)

Event Date 06/17/2015

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a carto 3 system and went into tachycardia which required a cardioversion.The patient¿s medical history is unknown.It was reported that the offset of the body surface (bs) electrocardiogram (ecg) signals was too large.V6 signal was at the same height as v5 signal on the carto ecg monitor.The offset did not interfere with the procedure.Additional information was received on the event.During the programmed stimulation the patient developed a hemodynamic unstable tachycardia.Overstimulation did not bring the sinus rhythm back, so an emergency cardioversion was done.Everything was working fine before the cardioversion, then after the cardioversion the noise on the bs started and it was not possible to get a read of the signal.There was noise on the bs ecg during the case.There was a complete signal loss due to the catheter but after the catheter was changed the signal returned but with noise.The signal interference was on the bs channel as well as the carto and recording system.However, the physician did have at least one ecg signal available to monitor the patient¿s heart rhythm.There is no further information about hospitalization or if any additional intervention was performed.This procedure was completed, however this noise issue caused a future case to be cancelled since the physician cannot work with those signals for a confidense case which required clear signals.

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)(6).Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

Evaluation summary: (b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a carto 3 system and went into tachycardia which required a cardioversion.It was also reported that the offset of body surface (bs) electrocardiogram (ecg) signals was too large.Field service engineer (fse) visited the account.The bs ecg signal offset issue was not duplicated.Noise on bs ecg could not be duplicated either.Fse followed up the issue and supported the next case.During 5 hours of procedure the reported noise on the bs ecg was not duplicated.Fse performed carto 3 system atp tests according to service manual.All functional tests performed and passed.System is operational.The history of customer complaints associated with this carto 3 system was reviewed.Four out of 9 additional reported complaints may be related to the reported issue.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 2066 717; IS 2066717
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4903855
• MDR Text Key: 18890117
• Report Number: 3008203003-2015-00052
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/17/2015

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?: No
• 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: 06/17/2015
• Initial Date FDA Received: 07/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention