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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 Problem Image Orientation Incorrect (1305)
Patient Problem No Consequences Or Impact To Patient (2199)
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. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. Note. Date of event is unknown, as such, the field has been left blank. If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. Manufacturer's ref. # (b)(4).
 
Event Description
It was reported that a patient underwent cardiac ablation procedure with a carto¿ 3 system where an unexplained map shift occurred. It was reported that the carto¿ 3 system showed over 6 mm shifted up in the maps. There was no patient consequence. On 10/28/2020, biosense webster inc. Received additional information which indicated there was no error displayed on carto but the map was within acl tolerance. The issue was seen during remap after some ablation. It was approximately 6 mm difference or more of a shift. Noticeably different - the superior vein was where the inferior vein was previously. We noticed high forces within the map when the physician looked like he was far from the roof and floating. There was no cardioversion or patient movement. The originally reported map shift issue was considered non-reportable until bwi became aware of additional information on 10/28/2020 which confirmed there was no patient movement or cardioversion and reassessed the event as mdr reportable.
 
Manufacturer Narrative
It was reported that a patient underwent cardiac ablation procedure with a carto® 3 system where an unexplained map shift occurred. It was reported that the carto® 3 system showed over 6 mm shifted up in the maps. There was no patient consequence. Device evaluation details: the device evaluation has been completed. It was reported that the biosense webster inc. (bwi) field service engineer (fse) performed a preventative maintenance test in the lab and it passed inspection after the complaint was called in. The study data was requested by the device manufacturer to investigate the issue, however, the biosense webster inc. Representative reported that the workstation was replaced due to frequently recurring software crashes caused at previous cases, and the recordings related to the case are not available more. Based on the provided information the investigation of the map shift issue was not possible. Bwi representative confirmed that the issue has not occurred since then. The system is operational. A manufacturing record evaluation was performed for the carto 3 system with serial #(b)(4), and no internal action related to the reported complaint condition were identified. An internal corrective action has been opened to investigate map shifts. If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. Manufacturer's ref. # (b)(4).
 
Event Description
Hold smp 1. 22.
 
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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 drive
irvine, CA 92618
949789-868
MDR Report Key10870955
MDR Text Key228350874
Report Number2029046-2020-01787
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 09/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Received11/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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