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U.S. Department of Health and Human Services

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

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BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number M-4800-01
Device Problems Issue With Displayed Error Message (2967); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2016
Event Type  malfunction  
Manufacturer Narrative
The 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 map shift occurred on the carto 3 system during mapping phase of an atrial fibrillation procedure. After access across the septum was lost, the physician did not feel comfortable proceeding due to the map shift and aborted procedure. No error messages appeared, no patient movement was detected, and no cardioversion had taken place prior to the map shift. The approximate difference in catheter location before and after map shift was at least 26. 6 mm. The patient was under general anesthesia for at least six hours. The patient did not require extended hospitalization due to a medical condition caused by procedure cancellation. This is mdr reportable as map shifts without error message could be potentially caused by a system malfunction and pose a potential risk to patient.
 
Manufacturer Narrative
Due to the august 2015 fda maintenance where the 3500a codes were updated, the 3500a codes (evaluation codes) will be added until the biosense webster system is also updated. Therefore the following codes apply: (b)(4). It was reported that there was a map shift. Caller reported that there was no patient movement and no error message was displayed. Caller also reported that they lost transseptal and aborted the case. No active troubleshooting could be performed. Follow up with local fse was requested. Fse arrived on site for the system check. Full system test was performed and no problems were found with the system. System is ready for use. The history of customer complaints associated with carto 3 system # (b)(4) was reviewed. 1 out of (b)(4) additional reported complaints may be related to the reported issue. Dhr review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.
 
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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 Key5729414
MDR Text Key48510328
Report Number3008203003-2016-00024
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2016
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? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/18/2016
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

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