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BIOSENSE WEBSTER INC. CARTO 3 SYSTEM SIMILAR DEVICE FG540000, 510K # K042999 Back to Search Results
Catalog Number FG540000J
Device Problem Image Orientation Incorrect (1305)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/05/2019
Event Type  malfunction  
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)(6). Biosense webster manufacturer's reference number (b)(4) has two reports related to the same event: (1) mfr # 2029046-2019-03710 for product code d134805 (cardiac tamponade against the thmcl smtch sf bid, tc, d-f). (2) mfr # 2029046-2019-03711 for product code fg540000j (map shift against the carto 3 system).
Event Description
It was reported that a patient underwent ventricular tachycardia (vt) ablation procedure using two (2) pentaray nav high-density mapping eco catheter, one (1) thermocool® smart touch® sf bi-directional navigation catheter and a carto 3 system and suffered a cardiac tamponade requiring pericardiocentesis and a product malfunction of a map shift with the carto 3 system. During mapping in the right atrium with pentaray nav high-density mapping eco catheter #1, the visualization of the spine became unstable. The visualization matrix had the spines going on and off even within the normal range. So, the cable was changed and the catheter was reconnected but the issue continued. When metal value was checked, value of the catheter which was connected to the 20a port was displayed over 1000. Then, the catheter was changed to pentaray nav high-density mapping eco catheter #2 and the issue improved but the phenomenon of intermittent disappearance of the pentaray nav high-density mapping eco catheter¿s spine continued. After that, it was confirmed that the acquired geometry and visitag were shifted diagonally and downward. It was also reported that during ventricular tachycardia (vt) ablation in the left ventricle, a perforation was noticed after a significant decrease in blood pressure and confirmation of pericardial effusion by echocardiography. The ablation procedure was urgently cancelled. There was no sign of perforation at the time of exchanging the pentaray nav high-density mapping eco catheters. The perforation sign was noticed when the map shifted. Drainage was performed using open heart surgery to remove unspecified amount of fluid. The patient¿s condition was later reported as stable. The physician¿s opinion about the causality of the event is that the map shift may have contributed to the event. The customer¿s reported visualization issues are not considered mdr reportable since the potential risk that it could cause or contribute to a serious injury or death is remote. However, this complaint is reportable for the serious injury of cardiac tamponade and the malfunction of map shift.
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Type of DeviceSIMILAR DEVICE FG540000, 510K # K042999
Manufacturer (Section D)
33 technology drive
irvine CA 92618
Manufacturer (Section G)
4 hatnufah street
yokneam 20667 17
IS 2066717
Manufacturer Contact
gabriel alfageme
31 technology drive
irvine, CA 92618
MDR Report Key9144217
MDR Text Key195523155
Report Number2029046-2019-03711
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,Followup,Followup
Report Date 09/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberFG540000J
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse