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

Model Number M-4800-01

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Cardiac Tamponade (2226)

Event Date 07/27/2016

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

Event Description

It was reported that a patient underwent an ablation procedure for persistent atrial fibrillation with a carto 3 system and suffered a cardiac tamponade.During transseptal phase, a tamponade occurred.Remainder of the procedure was aborted.There is no information regarding medical or surgical intervention, patient condition at the time of complaint report, extended hospitalization, patient outcome, or physician's opinion regarding the cause of the adverse event.It was also reported that errors 257 and 1007 occurred.There is no further information regarding these errors.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The carto navigation system is a 3-d electro-anatomical cardiac navigation system.It provides 3-d anatomical reconstruction and real-time electrical activity of the heart, and provides real-time tracking of catheter tip location.There is no direct patient contact.Thus, these complications are likely related to the catheter, not the mapping system.Therefore, the carto system is considered to be a concomitant product.We currently do not have information regarding the ablation catheter used in this procedure; therefore, we are conservatively reporting the carto system.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an ablation procedure for persistent atrial fibrillation with a carto 3 system and suffered a cardiac tamponade.It was also reported that errors 257 and 1007 occurred the field service engineer (fse) visited the account, inspected the system and found it to be in good condition before the next case.Case support was carried out.No issues were noted during the case.The fse was later informed that no issues were seen during the next cases.System is operational.The history of customer complaints associated with carto 3 system # (b)(4) was reviewed.Four out of 19 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.

• 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: 5902656
• MDR Text Key: 52950476
• Report Number: 3008203003-2016-00030
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• 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
• Date Manufacturer Received: 07/27/2016
• 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