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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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BIOSENSE WEBSTER INC CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number FG540000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Ventricular Tachycardia (2132)
Event Date 11/19/2019
Event Type  Death  
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. If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident. Reports 2029046-2019-04022 and 2029046-2019-04016 are related to this same incident. Manufacture ref no: (b)(4).
 
Event Description
It was reported that a (b)(6) male patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a carto 3 system and a thermocool smart touch sf bi-directional navigation (stsf) catheter and suffered ventricular tachycardia and death. There was an erasable programmable read only memory (eeprom) error displayed on the carto 3 system. Catheter replacement resolved the issue. In the middle of the case, char was noticed on the tip of the catheter. The catheter was cleaned, reinserted in the body, and the procedure continued. Later in the case, the catheter was pulled out of the body, and more char was noticed on the tip of the catheter. While mapping with the ablation catheter, data streaming errors (278, 268 & 258) displayed on the carto 3 system. The patient interface unit (piu) was shut down and rebooted. Troubleshooting was performed and the location pad was disconnected and reconnected. However, errors continued to display. The study was exited and reopened with no resolution. The patient interface unit (piu) and the workstation were then completely shut down. Thereafter, the workstation was booted up. A new study with a default template was opened then the piu was powered. The issue resolved. After resolving the data streaming errors, the case was canceled, as the patient was not stable enough to continue the treatment of arrhythmia. Electrocardiogram (ecg) signals and right ventricular pace was not able to be seen while the carto 3 system was down. However, the physician did have at least one ecg signal available to monitor patient¿s heart rhythm. There were no issues related to temperature or flow of the catheter. Generator was set to power control mode with a cutoff of 45 watts. The patient received and unknown anticoagulant during the procedure. The activated clotting time was 250-300 seconds, which was maintained for the bulk of the procedure. No ablations were over 60 seconds or 40 grams. Default pre-ablation high setting was used. Heparinized saline was used as irrigation fluid with default irrigation settings. Visitag parameters were set to: respiration, 2. 5mm stability, 25% 5g force over time, 2mm tag size, and tag index color option. This was a 3rd repeat ischemic ventricular tachycardia (vt) ablation for that patient. Only stsf was used for mapping due to physician¿s concern of inducing vt with pentaray. About 1. 5 hour into mapping in the ventricle wall, the catheters disappeared, and all the signals disappeared on the carto and the recording system. The biosense webster inc. (bwi) representative spent 23 minutes with the technical services on the phone, and eventually was advised to open a new study. The new study resolved the issue. The physician indicated 2 hours of the procedure was lost. During the troubleshooting, the patient developed vt several times and defibrillation was performed 3 times. After the 3rd shock the vitals started to drop, the heart started getting weaker and weaker and even though there were qrs complexes were visible. The blood pressure was very low (26/10-s), resulting in chest compressions being initiated. The physician decided to perform several more ablations and the case was stopped. The ablation procedure was stopped before reaching the physician¿s desired endpoint due to severe hypotension. Physician indicated the exact cause of this hypotension is unknown. Physician opinion is that the prolonged anesthesia led to drop in blood pressure. The catheter was used with default irrigation settings. Same issue happened to the same patient on (b)(6) for a previous vt ablation with carto on the same system with the same piu, with a different bwi representative. They never saw these errors except for these two cases. Per the physician, extended hospital stay was required. The patient was hospitalized but may not be due to the procedure but due to the patient¿s underlying condition. Patient passed away during hospitalization as a result of ventricular tachycardia.
 
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Brand NameCARTO 3 SYSTEM
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
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
gabriel alfageme
31 technology drive
irvine, CA 92618
949789-868
MDR Report Key9492766
MDR Text Key171955229
Report Number2029046-2019-04022
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFG540000
Device Catalogue NumberFG540000
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/18/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/19/2019 Patient Sequence Number: 1
Treatment
CARTO 3 SYSTEM; THMCL SMTCH SF BID, TC, D-F; THMCL SMTCH SF BID, TC, D-F
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