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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 No Device Output (1435)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/10/2020
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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number pc-000652551 has two complaints that are related to the same incident.Reports 2029046-2020-00358 and 2029046-2020-00357 are related to this same incident.Manufacture reference no: (b)(4).
 
Event Description
It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a carto 3 system, and a map shift issue occurred.At the beginning of an atrial fibrillation (afib) ablation procedure, the fast anatomical map (fam) matched with the contours taken by the soundstar® eco diagnostic ultrasound catheter.After the ablation started, the map shifted, and the left atrium looked more inferior.A combination of erasing and famming was used to get the anatomy close, but it never was the same.No error message was displayed on the system, the map shift was discovered when attempting to put the pentagram in the left veins after ablated the right veins.The approximate difference in catheter location before and after mapping is unknown.However, it was reported the difference was extensive.No cardioversion or patient movement occurred prior to the map shift.No patient consequences were reported.The observed map shift has been assessed as an mdr reportable malfunction.
 
Manufacturer Narrative
It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a carto 3 system, and a map shift issue occurred.The investigational analysis completed 5/14/2020.The issue was investigated.It was found that the issue occurred due to high metal level during contour recording.It was also found that alert 6401: "ultrasound: magnetic distortion" appeared during contour taking.According to the instructions for use (ifu): "a distortion in the magnetic field has been detected near the soundstar® catheter.Mapping is not recommended under these conditions." the contours were taken despite this alert.This issue was related to user error.The manufacturing record evaluation was performed and no internal actions were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).
 
Manufacturer Narrative
(b)(4).As the product has not been received, the investigation was limited to the information provided.We have not been provided with x-rays or any supporting documentation which could provide additional information.The item number and lot number identification necessary to review manufacturing history and the complaint history was not provided.Without the opportunity to examine the complaint product and without adequate information received regarding the event, root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
CARTO 3 SYSTEM
Type of Device
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
BIOSENSE WEBSTER INC
33 technology drive
irvine CA 92618
MDR Report Key9795577
MDR Text Key195903297
Report Number2029046-2020-00358
Device Sequence Number1
Product Code DQK
UDI-Device Identifier10846835000870
UDI-Public10846835000870
Combination Product (y/n)N
PMA/PMN Number
K133916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFG540000
Device Catalogue NumberFG540000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/10/2020
Initial Date FDA Received03/05/2020
Supplement Dates Manufacturer Received05/14/2020
06/19/2020
Supplement Dates FDA Received06/09/2020
06/19/2020
Patient Sequence Number1
Treatment
CARTO 3 SYSTEM; SOUNDSTAR ECO GE 10F CATHETER
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