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

Model Number M-5830-01

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Tamponade (2226)

Event Date 05/22/2015

Event Type  Injury  

Event Description

It was reported that a patient, (b)(6), male, underwent a left sided ventricular tachycardia ablation procedure with a carto # rmt system and suffered a cardiac tamponade, which required warfarin reversal with prothrombinex.Tamponade occurred when the physician was performing transseptal puncture with an unknown needle.Some contrast was seen in pericardial space.This is a known risk of the procedure.A hole was thought to be located at the superior interatrial septum with a 13 mm effusion.The patient was given prothrombinex to reverse warfarin.No surgical intervention was required.The patient was reported to be in stable condition at the time the complaint was reported.Additional information received on the event that the patient¿s condition has improved.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.With the limited information available, a conservative approach has been taken to report this event.

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).

Manufacturer Narrative

Evaluation summary.(b)(4).It was reported that a patient, (b)(6) male, underwent a left sided ventricular tachycardia ablation procedure with a carto # rmt system and suffered a cardiac tamponade, which required warfarin reversal with prothrombinex.The carto 3 is a non-invasive device and therefore, could not cause the effusion directly.However, with the limited information available, a conservative approach was taken to report this event under the carto 3 system.There was no reported deficiency with the carto 3 system used during the procedure.The customer did not request service for the carto system.The history of customer complaints associated with this carto 3 system was reviewed.Two additional reported complaints may be related to the reported issue.Device history record (dhr) review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.

• Brand Name: CARTO 3 RMT 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: 4847566
• MDR Text Key: 5807077
• Report Number: 3008203003-2015-00042
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K090017
• 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: 05/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M-5830-01
• Device Catalogue Number: FG560000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 62