MAUDE Adverse Event Report: STOCKERT GMBH SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US); CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	M490008
Medical Device Problem Codes	Failure to Sense (1559); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Air Embolism (1697); Ischemic Heart Disease (2493)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient in her 50¿s underwent a paroxysmal atrial fibrillation (afib) cryoablation procedure with a smartablate¿ system irrigation pump (us) and the patient suffered air embolism and electrocardiogram st segment elevation.The physician suspected that bubbles were present but that the smartablate¿ system irrigation pump (us)did not display a bubble error.During the paroxysmal afib case, a biomedical engineer, that the cath lab tech noticed microbubbles running through the tubing set and then into the patient.It is unknown if the tubing set was connected to a catheter or sheath.A suspected air embolism occurred after the medtronic flexcath sheath was inserted in the left atrium.The bwi representative reported that there was st elevation on the ekg and that the patient's blood pressure had dropped.When they moved the medtronic flexcath sheath back to the right atrium, the blood pressure issue and st elevation issue were both resolved.The bwi representative reported that an air embolism was not confirmed by ice and the procedure was continued.The patient was reported to be in stable condition as the "patient was able to push them out".There were no catheters inside of the patient's body when the issue occurred.The physician suspected that bubbles were present but that the smartablate¿ system irrigation pump (us) did not display a bubble error.The bwi representative noted that they tested the smartablate¿ system irrigation pump (us) while not connected to the patient by generating bubbles and flushing them through and the smartablate¿ system irrigation pump (us) generated bubble errors.This adverse event was discovered post use of the smartablate¿ system irrigation pump (us).The physician¿s opinion on the cause of this adverse event is that it was due to bwi product malfunction.No intervention was provided, issue resolved on its own.The patient is fully recovered for the adverse event.Patient has a history of cancer and chemo.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.Manufacturer's ref.# (b)(4).

• Brand Name: SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US)
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• MDR Report Key: 15196692
• Report Number: 2029046-2022-50009
• Device Sequence Number: 2239533
• Product Code: LPB
• UDI-Device Identifier: 04260166371093
• UDI-Public: 04260166371093
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2022
• Report Date (Section F): 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M490008
• Device Catalogue Number: M490008
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/14/2022
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC FLEXCATH SHEATH; SMARTABLATE GENERATOR KIT-US; SMARTABLATE IRR TUBE SET; SMARTABLATE PUMP KIT-US
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Female