MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO 3 SYSTEM; CARTO 3 EP NAVIGATION SYSTEM

Catalog Number UNK_CARTO 3

Device Problem Electro-Static Discharge (2149)

Patient Problem Inflammation (1932)

Event Date 08/21/2017

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).There are 4 impacted products being reported under (b)(4) fda report# 9673241-2017-01063, 3008203003-2017-01360, 9673241-2017-01064 and 9673241-2017-01065.

Event Description

It was reported that a patient underwent an ablation procedure for ventricular tachycardia (vt) with two thermocool smarttouch unidirectional catheters, a carto 3 system and a cable and suffered pericarditis requiring hospital readmission.During the procedure, a force sensor error populated.Smarttouch catheter # 1 was exchanged for smarttouch catheter # 2 and the procedure continued.There were no patient consequences as a result of this error.During the procedure, there was significant signal interference of body surface and intracardiac electrocardiograms (ecg) followed by the loss of all ecg signals.During the signal interference, an image was observed on the intracardiac ultrasound that was similar to the image that appears during ablation, but no ablation was being performed.Troubleshooting was performed and the issue persisted.Upon disconnecting the catheter cable, the issue was resolved.Catheter cable was replaced and the procedure continued.Post-procedure, the patient developed severe pericarditis.Since there were no medical issues apparent during ablation, the team is attributing the symptoms to a possible current leakage related to the catheter cable, procedure room equipment, or the hospital power grid.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The force issue is not mdr reportable as the potential that it could cause or contribute to a death, serious injury, or other significant adverse event is remote.However, the since it cannot be confirmed that any signal was available to monitor patient heart rhythm, the signal loss is mdr reportable.In addition, the potential current leak is also being conservatively reported since it was identified as a potential contributing factor to the adverse event.Furthermore, since prolonged hospitalization (re-admission) was required as a result of the adverse event, the patient event is also mdr reportable.

Manufacturer Narrative

Multiple attempts have been made to obtain clarification on which system was used during this procedure.However, no further information has been made available.Since there is no clarification, no product failure analysis can be conducted and no determination of possible contributing factors could be made.If additional information is received regarding clarification of the system used in this event, a supplemental 3500a report will be submitted to the fda.Since no serial number was provided, no device history record (dhr) review could be performed.(b)(4).

• Brand Name: CARTO 3 SYSTEM
• Type of Device: CARTO 3 EP NAVIGATION SYSTEM
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: evgeniya degnera ; 33 technology dr; irvine, CA 92618 ; 909839-723
• MDR Report Key: 6869829
• MDR Text Key: 86423710
• Report Number: 3008203003-2017-01360
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K090017
• 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: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_CARTO 3
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization