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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 Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/09/2018
Event Type  malfunction  
Manufacturer Narrative
Additional information was received january 24, 2018. Device history record review was performed by the manufacturer and no anomalies, which are related to the reported issue, were noted in manufacturing or servicing of this equipment. Product complaint # (b)(4).
 
Manufacturer Narrative
It was reported that a patient underwent a procedure for paroxysmal atrial fibrillation with a carto 3 system where there was a procedure delay. At the beginning of the case, there was a communication error with the carto. It took over an hour for the unit to properly initialize. This resulted in an hour-long case delay, but the procedure was able to be successfully completed with no patient consequences reported. Product investigation summary: the biosense webster inc. (bwi) field service engineer (fse) replaced the patient interface unit (piu) and resolved reported issue. Annual maintenance was also performed successfully. System is ready for use. The replaced piu was sent to the device manufacturer for investigation/repair. The device manufacturer concluded the customer complaint was confirmed. The dc/dc card in the piu was found to have failed and causing the communication issue. The dc/dc card was repaired and the piu returned to normal function. Device history record (dhr) review was performed by the manufacturer and no anomalies, which are related to the reported issue, were noted in manufacturing or servicing of this equipment. Manufacturer's ref # (b)(4).
 
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)(4).
 
Event Description
It was reported that a patient underwent a procedure for paroxysmal atrial fibrillation with a carto 3 system where there was a procedure delay. At the beginning of the case, there was a communication error with the carto. It took over an hour for the unit to properly initialize. This resulted in an hour long case delay, but the procedure was able to be successfully completed with no patient consequences reported. The physician had already performed the transseptal puncture, and the sheath (st. Jude medical sl0) was inside the left atrium while waiting for the carto system to initialize. During this time, the patient was anticoagulated and being monitored. The physician assessed the delay as a potential risk, as the patient had already been anticoagulated and had the transseptal performed. As a result, this event is mdr reportable.
 
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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
MDR Report Key7200806
MDR Text Key281955485
Report Number2029046-2018-01081
Device Sequence Number1
Product Code DQK
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,foreig
Type of Report Initial,Followup,Followup
Report Date 01/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2018
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2018
Is This a Reprocessed and Reused Single-Use Device? No

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