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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 Problems Computer Software Problem (1112); Patient Device Interaction Problem (4001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  Injury  
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. Manufacturer's ref. # (b)(4).
 
Event Description
It was reported that a patient underwent an atrial tachycardia (at) ablation procedure with a carto® 3 system wherein a piu issue occurred, and the remainder of the procedure was cancelled. It was reported that during the procedure, an error 24 ¿carto location pad issue¿ appeared on the carto® 3 system. Also, a red light was observed at the back of the piu. Unspecified troubleshooting was required but the issue remained despite troubleshooting. The physician decided to abort the procedure as no other system was available at the facility to rebook the case. The patient was cardioverted to prevent heart failure symptoms while waiting for the case to be rebooked. The error appeared before any anesthesia was given to the patient. Prolonged hospitalization was not required. Per carto ifu, the error 24 is related to failure in piu mag tx card bit. This piu issue alone is not considered not mdr reportable since the most likely consequence is an intraprocedural delay. The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote. On 6/2/2021, additional information was received which indicated the physician considers the case cancellation to be an increased risk for the patient as the patient had a cardioversion to temporarily improve his heart failure symptoms. It is likely the patient experienced an exacerbation of disease due to case cancellation; the continuation of disease due to failure to terminate atrial tachycardia (at) due to case cancellation. The heart failure symptoms was a pre-existing congenital patient condition. Based on the additional information received on june 2, 2021, this event has been reassessed as mdr reportable.
 
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Brand NameCARTO 3 SYSTEM
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
BIOSENSE WEBSTER INC
31 technology drive, suite 200
irvine CA 92618
Manufacturer (Section G)
BIOSENSE WEBSTER (ISRAEL) LTD.
4 hatnufah street
yokneam 20667 17
IS 2066717
Manufacturer Contact
gabriel alfageme
31 technology dr
irvine, CA 92618
9497898687
MDR Report Key12059659
MDR Text Key266896290
Report Number2029046-2021-00988
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUK
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 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received07/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/24/2021 Patient Sequence Number: 1
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