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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 Problems Signal Artifact/Noise (1036); Computer Software Problem (1112); Patient Device Interaction Problem (4001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2021
Event Type  Injury  
Manufacturer Narrative
Device evaluation details: field service engineer performed troubleshooting onsite and was unable to replicate the issue with account 12 lead and field service engineer electrocardiogram testing cable. Field service engineer tested the system per the acceptance testing procedure, and all requirements passed. The system is functioning as expected and is ready for use. Non-manufacturing related potential cause has been identified, therefore no manufacturing record evaluation is required. 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 during an atrial fibrillation (afib) ablation procedure, the carto(r) 3 system had error 1201 ecg (electrocardiogram) lead limb disconnection as well as a 19 failure in the patient interface unit (piu) ecg1 cart bit intermittently. The disposable limb lead patches were replaced, the electrocardiogram (ecg) cable was reseated and the patient interface unit was rebooted; however, the issue did not resolve. The patient interface unit and workstation were rebooted but the issue remained. The 12 lead body surface cable was replaced, and the issue remained. Reminder of the procedure was aborted. No ablation therapy could be performed. The physician was able to monitor patient's heart rhythm through the anestesia ecg monitor at all time. The patient was under general anesthesia for 1 hour and 50 minutes. No transseptal puncture was done prior to the case cancellation. The physician did not consider that cancelling the procedure represented an increased risk to the patient. There was no exacerbation of patient's disease. No additional intervention nor prolonged hospitalization were required. The ecg lead limb disconnection is not mdr-reportable. The piu 19 issue is not mdr-reportable. However, the absence of treatment 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
Manufacturer (Section G)
BIOSENSE WEBSTER (ISRAEL) LTD.
4 hatnufah street
yokneam 20667 17
IS 2066717
Manufacturer Contact
gabriel alfageme
31 technology dr
irvine, CA 92618
9497898687
MDR Report Key11305448
MDR Text Key231210721
Report Number2029046-2021-00148
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFG540000
Device Catalogue NumberFG540000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/25/2012
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: 02/09/2021 Patient Sequence Number: 1
Treatment
UNSPECIFIED ECG CABLE
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