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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STOCKERT GMBH SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US); CARDIAC ABLATION PERCUTANEOUS CATHETER
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STOCKERT GMBH SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US); CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Model Number M490008
Device Problems No Audible Alarm (1019); Decreased Pump Speed (1500); Patient Device Interaction Problem (4001)
Patient Problem Stroke/CVA (1770)
Event Date 01/17/2023
Event Type  Injury  
Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster inc.'s reference number (b)(4) has two reports: manufacture report number # 2029046-2023-00663 for product code unk_smart touch bidirectional (thermocool® smart touch¿ bi-directional navigation catheter) importer report number # 2029046-2023-50008 product code m490008 (smartablate¿ system irrigation pump (us)).
 
Event Description
It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and a smartablate¿ system irrigation pump (us) and the patient experienced a cerebrovascular accident.It was reported that the ablation device failed to alarm low fluid level.When air was visualized in line behind liquid, the line did shut down when the air sensed.Patient suffered post operative stroke.Multiple attempts have been made to obtain additional information and clarification to this complaint.However, no further information has been made available.
 
Manufacturer Narrative
On 4-jul-2023, the f10.Medical device problem code was updated from no audible alarm (a160102) to decreased pump speed (a141201) as this is a more appropriate code for the reported issue.Importer's ref # (b)(4).Correction: it was noticed the "hospitalization" box was not checked in section b2.Outcome attributed to adverse event of the 3500a supplemental (follow-up) #1.As such, the box has now been check marked.
 
Manufacturer Narrative
On 11-may-2023, additional information about the patient and event was received.It was reported that the adverse event was discovered post use of biosense webster products.The physician¿s opinion on the cause of this adverse event was air in line which had the potential to result in patient¿s post procedure stroke.Intervention included the machine being shut off.The equipment was exchanged, the patient is receiving ongoing care for stroke.The patient¿s outcome from the adverse event was reported as improved.Patient required extended hospitalization because of the adverse event as patient required follow up stroke care and monitoring post cardiac ablation.A smartablate generator was used in this case with the correct catheter settings selected on the generator and the smartablate irrigation pump switching was from "low" to "high" flow during ablation.There was no evidence of char during the procedure.No evidence of blood thrombus / clot during the procedure.The sensor correctly identified presence of air in the circuit, alarmed, and shut off the irrigation pump.However, air was present in the line distal to the bubble sensor.The smartablate generator continued to show fluid remaining, though the full liter bag was empty.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Importer's ref.# (b)(4) correction: it was noticed the information reported in section "e4.Reporter also sent report to fda?" of the 3500a initial mdr was incorrect as ¿unknown¿.It should have been ¿yes¿ as such, the field has now been updated.
 
Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Importer ref # (b)(4) on 29-aug-2023, it was noticed the device serial # was inadvertently omitted from the 3500a initial medwatch report.As such, field d4.Serial has now been populated.
 
Manufacturer Narrative
It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and a smartablate¿ system irrigation pump (us) and the patient experienced a cerebrovascular accident.It was reported that the ablation device failed to alarm low fluid level.When air was visualized in line behind liquid, the line did shut down when the air sensed.Patient suffered post operative stroke.Device evaluation details: no failure was found with the device.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported complaint condition were identified.All devices are manufactured, inspected, and released to approved specifications as part of biosense webster's quality process.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Importer ref # (b)(4).
 
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Brand Name
SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US)
Type of Device
CARDIAC ABLATION PERCUTANEOUS CATHETER
Manufacturer (Section D)
STOCKERT GMBH
boetzinger strasse 31
freiburg, b-w D-791 11
GM  D-79111
MDR Report Key16844349
MDR Text Key314294596
Report Number2029046-2023-50008
Device Sequence Number1
Product Code LPB
UDI-Device Identifier04260166371093
UDI-Public04260166371093
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Risk Manager
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/03/2023,09/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM490008
Device Catalogue NumberM490008
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/13/2024
Event Location Hospital
Date Report to Manufacturer03/03/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SMARTABLATE GENERATOR KIT-US; SMARTABLATE REMOTE SPARE-US; UNK_SMART TOUCH BIDIRECTIONAL SF
Patient Outcome(s) Life Threatening; Hospitalization;
Patient Age79 YR
Patient SexMale
Patient Weight80 KG
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