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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 Appropriate Term/Code Not Available (3191)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 11/20/2019
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. If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. (b)(4).
 
Event Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a carto® 3 system and suffered hypotension. During transesophageal echo study, with the patient under general anesthesia (20-30 min) the carto® 3 system displayed a chest patch sensor error. The patient interface unit (piu) was turned off and the green and yellow sensor cables reseated in piu. The piu and workstation were rebooted along with the patch unit being reseated. The issue did not resolve. They will borrow a set of yellow sensor cables and a patch unit from another hospital. They will also swap the green and yellow sensor cables for testing purposes. The yellow patch cables did not seem to sit tightly into the patch unit. The patient¿s blood pressure was unstable, and the anesthesia was getting anxious. It was going to take at least 30 minutes to get a patch cable from another hospital. Therefore, the physician said to take the patient off the table and cancel the case. The cable was eventually borrowed from another hospital to do the next procedure. In the physician¿s opinion, the cancellation of the procedure did not contribute to a serious injury of the patient. The patient was hospitalized overnight but no procedure other than the transesophageal echocardiogram (tee) was performed. The patch sensor error was assessed as not reportable. Since it was not life threatening, did not result in permanent impairment of a body function or permanent damage to a body structure; or did not necessitate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, the potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote. There is no indication that the patient¿s hypotension resulted from the use of the system; therefore, the carto® 3 system will be considered concomitant for the patient event and not reportable. The issue assessed as reportable was the procedure cancellation after extended general anesthesia time.
 
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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 Key9491919
MDR Text Key199723482
Report Number2029046-2019-04023
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
Report Date 11/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2019
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2013
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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