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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 UNK_CARTO 3
Device Problems Failure to Transmit Record (1521); Patient Device Interaction Problem (4001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2021
Event Type  Injury  
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 with an unknown history had an ablation procedure with a pentaray nav high-density mapping eco catheter. The pentaray catheter was not recognized by the carto system; troubleshooting with field technician; issue relates to possibly faulty workstation. The patient was under anesthesia for 1. 5 hours, vascular access was done and transseptal puncture performed when the case was cancelled. In addition during the case the patient suddenly stopped responding during the procedure, and the physician immediately sent the patient to the brain ct scan with suspicion of brain hemorrhage. Upon follow up it was stated patient stayed extra night in the hospital. Afterwards, the patient recovered fully. The inability of the carto® 3 system to recognize the device is not mdr-reportable. However, since the event is life-threatening and required intervention to prevent permanent impairment of a body function or permanent damage to a body structure, then it is to be considered serious and mdr-reportable. This report is being reported for both the carto® 3 system. The report for the pentaray nav high-density mapping eco catheter can be found in manufacturer report number 2029046-2021-00256.
 
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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 INC (JUAREZ)
circuito interior norte
1820parque industrial salvacar
juarez 32599
MX 32599
Manufacturer Contact
gabriel alfageme
31 technology dr
irvine, CA 92618
9497898687
MDR Report Key11402317
MDR Text Key240651393
Report Number2029046-2021-00258
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeNO
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
Report Date 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_CARTO 3
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 Received05/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/02/2021 Patient Sequence Number: 1
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