• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number M-4800-01
Device Problems Image Display Error/Artifact (1304); Invalid Sensing (2293); Failure to Align (2522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2016
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. (b)(4).
 
Event Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system. Near the end of the procedure during ablation, a map shift occurred. No errors were present. There was no cardioversion performed nor patient movement noted prior to the map shift. The significant map shift of approximately 3mm plus was noticed when ablation points began appearing in the middle of the fast anatomical mapping geometry. They made a new left atrium map to continue with the procedure. There were no further issues and no patient consequence. Afterwards, they noted that the defibrillation pad was overlapping one of the c3 back patches. The issue resolved when the patches were placed properly. This event has been assessed as a reportable malfunction as such map shifts without an error message could potentially be caused by a system malfunction and there would be a potential risk to the patient.
 
Manufacturer Narrative
(b)(4). It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system. Near the end of the procedure during ablation, a map shift occurred. No errors were present. There was no cardioversion performed nor patient movement noted prior to the map shift. The significant map shift of approximately 3mm plus was noticed when ablation points began appearing in the middle of the fast anatomical mapping geometry. They made a new left atrium map to continue with the procedure. There were no further issues and no patient consequence. The biosense webster field service engineer contacted the biosense webster field representative regarding this issue. The biosense webster field representative was covering this procedure. Afterwards, they confirmed that the defibrillation pad was overlapping one of the c3 back patches. Issue resolved when the patches were placed properly. This is a user error issue. System is operational. The device history record (dhr) review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCARTO® 3 SYSTEM
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
BIOSENSE WEBSTER (ISRAEL) LTD.
4 hatnufah street
yokneam 20667 17
IS 2066717
Manufacturer (Section G)
BIOSENSE WEBSTER (ISRAEL) LTD.
4 hatnufah street
yokneam 20667 17
IS 2066717
Manufacturer Contact
joaquin kurz
33 technology drive
irvine, CA 92618
9497893837
MDR Report Key6146621
MDR Text Key61723611
Report Number3008203003-2016-00040
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
Report Date 11/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM-4800-01
Device Catalogue NumberFG540000
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/09/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

-
-