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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM SIMILAR DEVICE FG540000, 510K # K042999

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BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM SIMILAR DEVICE FG540000, 510K # K042999 Back to Search Results
Model Number FG-5400-00J
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)
Event Date 06/28/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). It was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto 3 system and suffered ventricular tachycardia (requiring intracardiac defibrillation), ventricular fibrillation (requiring external defibrillation and percutaneous cardiopulmonary support), and bradycardia (requiring cardiac massage). The technical service team offered to inspect the customer¿s device, but service was declined. The history of customer complaints associated with carto 3 system # 50095 was reviewed. There were no additional complaints (out of 15 additional reported complaints) that 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. In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures. The customer complaint cannot be confirmed.
 
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. Concomitant products: unspecified coronary sinus and right ventricle catheters, fukuda denshi pacing stimulator. Manufacturer's ref. No: (b)(4). Biosense webster manufacturer reference numbers (b)(4) are related to the same incident.
 
Event Description
It was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto 3 system and suffered ventricular tachycardia (requiring intracardiac defibrillation), ventricular fibrillation (requiring external defibrillation and percutaneous cardiopulmonary support), and bradycardia (requiring cardiac massage). During the procedure, after the coronary sinus (cs) catheter was inserted and while planned pacing was being performed from the right ventricular (rv) catheter, the patient went into ventricular tachycardia. Intracardiac defibrillation converted ventricular tachycardia to ventricular fibrillation, as the energy was delivered on the t-wave (during cardiac repolarization). External defibrillation terminated the ventricular fibrillation and converted the patient to sinus bradycardia. Cardiac massage was performed and percutaneous cardiopulmonary support (pcps) was initiated. Patient was transferred to the intensive care unit (icu). There is no information regarding extended hospitalization. Patient outcome is improved. It was noted that the physician indicated that he inadvertently requested intracardiac defibrillation. Physician¿s opinion regarding the cause of the adverse event is that it was related to procedure or patient condition. There is no information regarding spi value, catheter proximity, or catheter zeroing. Carto did not allow pacing and ablating at the same time. Pacing was planned. No unwanted pacing was delivered. This event was previously reported under report #9673241-2017-00581, which was filed against a generic catheter catalog number. However, additional follow up determined that this carto 3 system was the only bwi product in use. As such, it will now be reported with this manufacturer¿s reference number.
 
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Brand NameCARTO® 3 SYSTEM
Type of DeviceSIMILAR DEVICE FG540000, 510K # K042999
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 Key6742408
MDR Text Key120144599
Report Number3008203003-2017-00028
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFG-5400-00J
Device Catalogue NumberFG540000J
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/28/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/25/2017 Patient Sequence Number: 1
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