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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 Image Orientation Incorrect (1305)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/21/2020
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.Manufacturer's reference number: (b)(4).
 
Event Description
It was reported that a patient underwent an atrial flutter right (r-afl) procedure with a carto® 3 system and a map shift occurred with no error message, no change in posture or position and no cardioversion.It was reported that there was map shift error and the ablation catheter appeared to be outside of the heart but the fluoroscopy appeared to be in the same place.The catheter cable was replaced and the issue remained.The catheter was replaced and the issue resolved.Additional information was received on january 23, 2020.There was no error message.The issue was seen during mapping.The shift appeared to be a centimeter plus off.No cardioversion was performed.There was no report of patient consequence.Although the issue was stated that it resolved by replacing the catheter, since the caller implied a map shift, the map shift issue is assessed to be investigated under the carto® 3 system.This map shift issue described was assessed as not reportable.Additional information was received on march 12, 2020 stating there was also no change in posture or position of the patient.The map shift issue with no error message, no change in posture or position and no cardioversion has been assessed as a reportable malfunction.This awareness date for this reportable malfunction is march 12, 2020 as this is the date of when we received the additional information that there was also no posture or position changes.
 
Manufacturer Narrative
On 7/5/2020, the product investigation was completed.It was reported that a patient underwent an atrial flutter right (r-afl) procedure with a carto® 3 system and a map shift occurred with no error message, no change in posture or position and no cardioversion.It was reported that there was map shift error and the ablation catheter appeared to be outside of the heart but the fluoroscopy appeared to be in the same place.The catheter cable was replaced and the issue remained.The catheter was replaced and the issue resolved.Additional information was received on january 23, 2020.There was no error message.The issue was seen during mapping.The shift appeared to be a centimeter plus off.No cardioversion was performed.There was no report of patient consequence.Device investigation details: the issue was investigated under ir #86605.The study data was requested by htc to investigate the issue.Cas reported that the data isn't available because it was deleted from the system.Investigation of the map shift issue was not possible.The cas also confirmed that the issue was not duplicated since then and no service was required.The complaint history of the system was reviewed and no more similar problems were found since the issue occurred.The system is ready for use.The history of customer complaints reported during the last year associated with carto 3 system #29094 was reviewed.No similar complaints were found there out of 8 additional complaints.A manufacturing record evaluation was performed for the system 29094, and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
 
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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 Key9875228
MDR Text Key200483628
Report Number2029046-2020-00469
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
Report Date 01/21/2020
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
Initial Date Manufacturer Received 03/12/2020
Initial Date FDA Received03/24/2020
Supplement Dates Manufacturer Received07/05/2020
Supplement Dates FDA Received07/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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