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

Model Number M-4800-01

Device Problems Communication or Transmission Problem (2896); Computer Operating System Problem (2898)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 07/08/2015

Event Type  Injury  

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).Biosense webster manufacturer's ref.No.'s (b)(4) are related to the same incident.Event description continuation: this event was previously reported under the suspect device, thermocool® smarttouch® bi-directional navigation catheter, mfr.Report no: 9673241-2015-00497.However, a bwi quality management review board met on 8/26/2015 and assessed that the combination of the carto system crash and the soundstar loss of connectivity due to this crash.If this disruption occurs during active monitoring of an effusion (as demonstrated in this complaint), then this may pose a patient safety risk as the lack of monitoring can lead to a delay in diagnosing a cardiac tamponade and delay treatment.As such, the awareness date for this 5-day report submission has been reset to 8/26/2015, the date of the management review meeting.

Event Description

It was reported that a female patient underwent an atrial fibrillation procedure with a thermocool smarttouch bi-directional navigation catheter, the patient suffered cardiac tamponade.Moments after the tamponade was noted, the physician attempted to monitor the effusion with a soundstar eco 8f siemens ultrasound catheter, however, the catheter could not be used because the adjoining carto mapping system crashed.At the moment the system restored, the soundstar catheter could not be identified and displayed an eeprom error, as the eeprom was now corrupt due to the carto crash.During this period while waiting for the carto workstation to reboot, the patient became increasingly hypotensive.The physician had to use a tte probe (ultrasound images that are taken through the chest wall).The physician then replaced the soundstar catheter and used an 8f acunav catheter which could be connected directly to the ultrasound system to monitor the injury.The patient required vasopressin administration, pericardiocentesis draining of a total of 1.5 liters, extended hospitalization under intensive care unit and open heart surgery.The patient was reported to be in stable condition.The physician did not provide a causality opinion for the cause of this adverse event and the patient's medical history is unknown.

Manufacturer Narrative

It was previously reported that this event type involved an adverse event however; this event involves both a product problem and an adverse event.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a female patient underwent an atrial fibrillation procedure with a carto 3 system and the patient suffered cardiac tamponade.The issue was clarified by the bwi representative.When the physician monitored the effusion with a soundstar catheter, connected to the carto 3 system, the workstation crashed and ultrasound (us) video stopped being displayed.When the workstation was rebooted the soundstar catheter could not be identified and eeprom error appeared.The physician switched to a transthoracic echocardiogram, replaced soundstar catheter with 8f acunav catheter which was connected directly to the us system to monitor the injury.The carto 3 is a non-invasive device and therefore, could not cause the pericardial effusion directly.However, the carto system crash caused the soundstar catheter to lose connectivity and delayed the patient treatment.Field service engineer (fse) sent the log data to device manufacturer for analysis.The issue was investigated by the device manufacturer.Opened sw bug#40314.Fse followed up with bwi representative who reported that the issue was not duplicated and was not experienced again.System is ready for use.The history of customer complaints associated with this carto 3 system was reviewed.There were not any additional complaints that 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 20667 17; IS 2066717
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 5048476
• MDR Text Key: 24775528
• Report Number: 3008203003-2015-00070
• 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
• Remedial Action: Notification
• Report Date: 07/08/2015

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?: 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: Not provided
• Initial Date FDA Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention