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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); Fitting Problem (2183); Patient Device Interaction Problem (4001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/19/2021
Event Type  Injury  
Manufacturer Narrative
Initial reporter phone: (b)(6). 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 information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. 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 fibrillation (afib) -persistent ablation procedure with a carto 3 system. The patient was under general anesthesia and a transseptal puncture had been made when the case was cancelled due to failure of the carto 3 system. During the procedure, map 1-2 was damaged, and every time the catheter was plugged in, everything would shut down, with no signal or noise on every signal catheter. An anesthesia monitor was available to monitor the patient¿s heart rhythm (ecg signal). The procedure could not be finished. The patient fully recovered with no residual effects and no extended hospitalization was required. The physician¿s opinion regarding the cause of this adverse event is that this was a biosense webster, inc. (bwi) product malfunction where map 1-2 port (back plane) was damaged. The bwi field service engineer, while on site, discovered a physically damaged short location pad cable. The cable and backplane card was replaced. Also, 2 pin boxes had bent pins inside the connector. 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.
 
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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
IS
Manufacturer Contact
gabriel alfageme
31 technology dr
irvine, CA 92618
9497898687
MDR Report Key11516936
MDR Text Key240681656
Report Number2029046-2021-00381
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K133916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2021
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 Answer Provided
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? Yes
Date Device Manufactured12/13/2009
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: 03/18/2021 Patient Sequence Number: 1
Treatment
UNKNOWN BRAND CATHETER
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