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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 Pacing Problem (1439)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/18/2020
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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2020-00915 for product code fg540000 (carto® 3 system).(2) mfr # 2029046-2020-00916 for product code unk_smart touch bidirectional (thermocool® smart touch¿ bi-directional navigation catheter).
 
Event Description
It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and the carto® 3 system and developed ventricular tachycardia (vt) requiring cardioversion and an unwanted pacing issue occurred.During the procedure while ablating the pvc, a signal on the body surface electrocardiogram (ecg) the observed what looked like a single pacing spike; however, no active stimulation was in course at that time.After the signal was observed, vt started.Cardioversion was performed, and the vt was stopped.The pacing leads were connected to the carto 3 main stim port.The pacing stimulator that was in use was a biotronic qubic stim.The physician wants to make sure if the spike was an optical artifact or an unwanted pacing spike that was guided through the carto 3 system despite the ablation.Pacing and ablating were not configured by the customer.Caller said that physician thought the unwanted spike signals caused the vt rhythm.Pacing was not planned or emergency.There¿s no indication that extended hospitalization was required as a result of the event.The patient adverse event will be reported under the thermocool® smart touch¿ bi-directional navigation catheter.
 
Manufacturer Narrative
It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and the carto® 3 system and developed ventricular tachycardia (vt) requiring cardioversion and an unwanted pacing issue occurred.During the procedure while ablating the pvc, a signal on the body surface electrocardiogram (ecg) the observed what looked like a single pacing spike; however, no active stimulation was in course at that time.After the signal was observed, vt started.Cardioversion was performed, and the vt was stopped.The pacing leads were connected to the carto 3 main stim port.The pacing stimulator that was in use was a biotronic qubic stim.The physician wants to make sure if the spike was an optical artifact or an unwanted pacing spike that was guided through the carto 3 system despite the ablation.Pacing and ablating were not configured by the customer.Caller said that physician thought the unwanted spike signals caused the vt rhythm.Device evaluation details: the device evaluation has been completed.Biosense webster inc.Field service engineer (fse) followed up on the issue with customer.The fse was informed that customer worked further with the carto 3 system and same smartablate generator and pump without reoccurrence of the reported issue.However, the customer still requested a system check.The fse visited the account and the carty 3 system was tested.All tests passed.Planned maintenance was performed successfully, and system found operational.Reported issue was investigated by the device manufacturer and it was confirmed that the user did not pace at this time; the spike was noted when the ablation started.It was seen that the spike reaches saturation level for m1, nothing seen on channel m2.The wide complex tachycardia (wct) and the rest of the body signal (bs) ecg showed a signal with decreasing amplitude.The opto-switch on the ecg channel m1 was suspected to be damaged.Technical service was requested to provide additional information regarding system behavior after the issue and it was requested to send the 3 ecg cards to the device manufacturer for investigation.However, fse confirmed that it was onetime issue.The customer did more than 25 procedures on indicated system since and did not observe any system malfunction and confirmed that the system is operational.The fse was warned about unwanted pacing issues and advised to send 3 ecg cards, backplane card, catheters and indifferent electrode for investigation to the manufacturer if the issue will be occurred once again.A manufacturing record evaluation was performed for the carto 3 system (serial: (b)(6)), and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (b)(4).
 
Manufacturer Narrative
On (b)(6) 2020, clarification was noted in the product investigation.It was previously reported that: ¿the fse visited the account and the carty 3 system was tested.All tests passed.Planned maintenance was performed successfully, and system found operational.Reported issue was investigated by the device manufacturer and it was confirmed that the user did not pace at this time; the spike was noted when the ablation started.It was seen that the spike reaches saturation level for m1, nothing seen on channel m2.¿ the investigation results were clarified to read as follows: ¿the fse visited the account and the carto 3 system was tested.All tests passed successfully.Preventative maintenance was performed successfully, and system found operational.Reported issue was investigated by the device manufacturer and it was confirmed that there was no active stimulation at all at that time; the spike was noted when the ablation started.It was seen that the spike reaches saturation level for m1, nothing seen on channel m2.A single spike occurred on m1 channel as soon as ablation has been started, while there was no spike on channel m2.Pacing spikes would be observed on both channels m1 and m2 if the channels were really stimulated.¿ if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
 
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Brand Name
CARTO 3 SYSTEM
Type of Device
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
BIOSENSE WEBSTER INC.
33 technology drive
irvine CA 92618
MDR Report Key10311654
MDR Text Key200459497
Report Number2029046-2020-00915
Device Sequence Number1
Product Code DQK
UDI-Device Identifier10846835000870
UDI-Public10846835000870
Combination Product (y/n)N
PMA/PMN Number
K133916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 09/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFG540000
Device Catalogue NumberFG540000
Date Manufacturer Received09/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BIOTRONIC QUBIC STIM PACING STIMULATOR; SMARTABLATE GENERATOR KIT-WW; SMARTABLATE PUMP KIT-WW; UNK_SMART TOUCH BIDIRECTIONAL
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