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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
Catalog Number FG540000
Device Problem Image Orientation Incorrect (1305)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2019
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. Manufacturer's reference # (b)(4).
 
Event Description
It was reported that a patient underwent an afib ¿ paroxysmal procedure with a carto® 3 system and it described that there was a map shift with no error message and no patient movement or cardioversion. Initially it was reported that during the setup of the paroxysmal atrial fibrillation procedure, the patient was attached to the patch sensors which were connected by the carto® 3 system. It was checked that back and chest patches were in mapping range on location setup window. The right inferior pulmonary vein (ripv) was ablated using thermocool® smart touch® sf bi-directional navigation catheter. And when the right superior pulmonary vein (rspv) was ablated, it was felt that something was wrong. It was confirmed that if the catheter position was on the pulmonary vein (pv) ostium by using x-ray (siemens, bi-plane cath lab system). However, the real catheter positioning was inside right superior pulmonary vein (rspv). At that time, there were no error messages about no patient movement. It was checked if the metal value was within normal range and the patch sensors were located in the mapping range. There were no issues. There was a possibility of affecting the phrenic nerves. The carto® 3 system was inspected with location patch sensor, and it was found to be working. Follow up was performed the following day on the patient and it was confirmed that there were no patient consequence. Attempts were made to obtain clarification to this complaint. However, no further information had been made available. With the information available, this issue was originally assessed as not reportable. Additional information was received on july 5, 2019, and it was reported that during the procedure, the physician did not perform a cardioversion and it was confirmed that they did not detect patient movement. In addition, by comparison between the initial map and map shift, the difference was over 1 mm (about 1 cm). Per the additional information received stating that there was no cardioversion and confirmation that there was no patient movement, this map shift was with no error message, patient movement or cardioversion was reassessed to a reportable issue. The awareness date for this report is july 5, 2019.
 
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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 Key8840767
MDR Text Key152800968
Report Number2029046-2019-03465
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K133916
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 06/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received08/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/16/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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