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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 Problem Invalid Sensing (2293)
Patient Problem Atrial Fibrillation (1729)
Event Date 01/10/2017
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. There was an electrocardiogram (ecg) signal loss on the carto 3 system and the recording system when the smart touch catheter was plugged into the carto patient interface unit during the procedure. They rebooted the system, unplugged and reconnected all cables. However, the issue continued. They also replaced three cables and two catheters. However, the issue continued. The procedure was cancelled as a result of this issue. There were no patient consequences. Additional information was received stating that they did have ecg signals available to monitor the patient¿s heart rhythm. The patient was under general anesthesia for a total of 2. 5 hours. A transseptal puncture was performed prior to the case cancellation. The patient required extended hospitalization as a result of the procedure cancellation. The physicians kept the patient at the hospital as the procedure was postponed until (b)(6) 2017. The signal loss issue was assessed as not reportable as the patient's heart rhythm was still visible to the operator when signal loss occurred. Therefore, the risk to the patient was low. The procedure cancellation was assessed as reportable malfunction as the cancellation required the patient to receive extra care.
 
Manufacturer Narrative
(b)(4). It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system. There was an electrocardiogram (ecg) signal loss on the carto 3 system and the recording system when the smart touch catheter was plugged into the carto patient interface unit during the procedure. They rebooted the system, unplugged and reconnected all cables. However, the issue continued. They also replaced three cables and two catheters. However, the issue continued. The procedure was cancelled as a result of this issue. There were no patient consequences. Additional information was received stating that they did have ecg signals available to monitor the patient¿s heart rhythm. The patient was under general anesthesia for a total of 2. 5 hours. A transseptal puncture was performed prior to the case cancellation. The patient required extended hospitalization as a result of the procedure cancellation. The physicians kept the patient at the hospital as the procedure was postponed until (b)(6) 2017. The biosense webster, inc. Field service engineer visited the account and resolved the issue by replacement of the backplane card. Preventive maintenance was successfully performed on the system. System is ready for clinical use. Replaced backplane card was sent to the device manufacturer for investigation. The customer complaint was confirmed. The card failed: the pins in the map connector were found damaged and caused the issue. The damaged connector was replaced. The device history record (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 Key6284915
MDR Text Key66252211
Report Number3008203003-2017-00002
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeBE
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
Report Date 01/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2017
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 Received01/10/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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