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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 Self-Activation or Keying (1557); Device Displays Incorrect Message (2591); Material Deformation (2976); Positioning Problem (3009); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/26/2016
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 during an afib - persistent procedure, the patient was under general anesthesia and a transseptal puncture had been performed. There was distortion on the catheter position. Also when the foot petal was pressed the catheter position would shift drastically. There was fluoroscopy and ultrasound available during the procedure to corroborate the catheters position. There was also noise on the body surface leads. No error displayed on the stockert generator or the carto 3 system. It was also reported that the cables, grounding pad, and the catheter were replaced without resolution. There was about a 10 minute delay while they changed out the cables, grounding pad and catheter. The procedure was continued with no patient consequence. The event was originally assessed as not reportable. For the noise issue, the patient's heart rhythm was still visible to the operator when the signal issue occurred. For the catheter visualization issues, the most likely consequence was an intraprocedural delay. The delay caused by these issues was approximately 10 minutes. The potential that it could cause or contribute to a death or serious injury, or other significant adverse event was remote. On may 3, 2016 additional information was received noting that there was a map shift on the main map viewer; however, no error displayed. The lateral map shift was about the length of 4 electrodes on the mapping catheter and it occurred during radio frequency. It was stated that this issue was never noted during subsequent procedures. Since there was no error message and no mention that there was any patient movement, this event has been conservatively assessed as a reportable malfunction as such map shifts could be a potential risk to patient. The awareness date is reset to may 3, 2016.
 
Manufacturer Narrative
(b)(4). It was reported that during an afib ¿ persistent procedure, the patient was under general anesthesia and a transseptal puncture had been performed. There was distortion on the catheter position. Also when the foot petal was pressed the catheter position would shift drastically. There was fluoroscopy and ultrasound available during the procedure to corroborate the catheters position. There was also noise on the body surface leads. No error displayed on the stockert generator or the carto 3 system. It was also reported that the cables, grounding pad, and the catheter were replaced without resolution. There was about a 10 minute delay while they changed out the cables, grounding pad and catheter. The procedure was continued with no patient consequence. Additional information was received noting that there was a map shift on the main map viewer; however, no error displayed. The biosense webster field service engineer visited the account. It was found during the follow up case that the map shift appeared due to improper patch placement. The patches were deemed to be too close to the edge of the magnetic field causing the map shift. The issue has not been noted since the case. Full atp testing was performed on the system. The system passed full atp. The system is ready for use. The biosense webster field service engineer confirmed that the foot pedal was found to not be defective. The biosense field service engineer clarified that the issue was not with the foot pedal, but rather with catheter distortion (map shift). The ecg noise issue was not duplicated. To be thorough and ensure the issue does not remain, the biosense field service engineer replaced the ecg card 1. No noise issues have been noted since this case. During the case support, a magnetic distortion error displayed when ablation was attempted. It was found that the ablation adapter cable was defective and caused the issue. The defective ablation adapter cable was replaced and the issue resolved. 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 Key5690082
MDR Text Key47308520
Report Number3008203003-2016-00017
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 04/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2016
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 Received04/26/2016
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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