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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 Date 09/12/2019
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 reference # (b)(4).
 
Event Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system and a map shift error occurred. It was initially reported that the catheter had required to be zeroed out many times throughout the case due to an invalid force measure. It was also noted that the map shifted 3 mm after ablating. On september 20, 2019, additional information was received indicating that the map shift was discovered by doing a post voltage map using confidence and a pentaray catheter. The voltage map showed healthy voltage approximately 3 mm to the left of the left pulmonary vein, wide antral circumferential ablation (waca) lesion on the posterior wall (when looking in a post anterior view) and showed scar (<0. 2 mv) to the left of the right pulmonary vein wide antral circumferential ablation (waca). No change occurred in patch location and all metal values were well below limits as the fluoroscopy system was never near the patient for the entirety of the case. No cardioversion was performed, and no posture change of the patient occurred. The catheter was not replaced, and no patient consequence was reported. The observed force issue was assessed as not mdr reportable. The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote. The observed map shift was assessed as an mdr reportable malfunction as map shifted with no error message, patient movement, or cardioversion.
 
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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 Key9160274
MDR Text Key193121767
Report Number2029046-2019-03731
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,Followup,Followup
Report Date 09/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2019
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 Received06/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2018
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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