• 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 INC. 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 INC. CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Catalog Number FG540000
Device Problem Image Orientation Incorrect (1305)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/31/2019
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. Manufacturer's ref # (b)(4).
 
Event Description
It was reported a patient underwent an atrial tachycardia (at) procedure with a carto 3 system and a map shift issue occurred. It was initially reported that during the mapping phase of an atrial tachychardia ablation procedure, an issue happened with software version 7. When attempting to collect data from one map, the map suddenly shifted around 3 cm. The issue was resolved by re-mapping. No delays reported. There were no patient consequences. The map shift issue was initially considered non-reportable since there was no information regarding possible cardioversion or patient movement. On 6/3/2019, additional information was received indicating that no error messages were displayed. Map shift discovered after doing a remap of a parallel map. Comparing both maps showed a displacement between both maps. The approximate difference in catheter location before and after the reported map shift was reported as 3. 50 mm (measured 2 identical locations using "distance measurement tool"). It was also reported that the physician did not perform cardioversion prior to the map shift and there was no patient movement. A software bug was suspected. This event was originally considered nonreportable, however, based on the additional information received on 6/3/2019, the event has been reassessed as mdr reportable as a malfunction since information was received indicated that no error messages were given by the system, the physician did not perform cardioversion prior to the map shift and there was no patient movement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 drive
irvine, CA 92618
949789-868
MDR Report Key8730628
MDR Text Key150164366
Report Number2029046-2019-03317
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K133916
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 05/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2019
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
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-