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

Model Number	M490008
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Air Embolism (1697); Cardiac Arrest (1762); Asystole (4442)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
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.Biosense webster inc.'s reference number (b)(4) has two reports: (1) manufacture report number # (b)(4) for product code d133602 (thermocool® smart touch¿ electrophysiology catheter) (2) importer report number # (b)(4) product code m490008 (smartablate¿ system irrigation pump (us)).
Event or Problem Description
It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and smartablate¿ system irrigation pump (us) ad the patient suffered asystole, air embolism and cardiac arrest.Upon ablation there was a high temperature alarm on the generator.The patient went into asystole and on fluoroscopy the heart was at standstill.Pacing was then started in the ventricle and did capture but the heart was still at standstill.Cardiopulmonary resuscitation (cpr) was then started and the patient was given emergency medication.The patient recovered but the bwi representative was not in the room at that time.It was also reported there was no ultrasound image on the carto and ultra sound (us) unit.There was also an unknown error.The bwi representative reseated the us cables and catheters.The soundstar catheter and eco-cable were replaced, and that issue resolved but the image was purple.Through troubleshooting it was determined that the cable needs replacement.Then the ablation irrigation bag was dry and a bubble alarm occurred.They flushed the lines and went to low flow.The adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was a bwi product malfunction air embolus from the ablation fluid bag and patient condition stable and recovered.The patient outcome of the adverse was fully recovered (no residual effects).The physician¿s opinion on the cause of this adverse event was a bwi product malfunction air embolus from the ablation fluid bag.The smartablate¿ system irrigation pump (us) did alarm for bubbles and the bag did not run dry.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.This event will be considered reportable against the ablation catheter and the pump.The pump tubing is connected to the ablation catheter which was ablating in the left atrium/pulmonary veins.There was a high temperature alarm which is possibly when the air embolism occurred.It is highly likely that an air embolism in the left ventricle from the ablation catheter would cause asystole/ cardiac arrest.It is less likely that an air embolism in the right atrium (likely location of the unknown sheath).The customer¿s reported high temperature issue is not mdr-reportable since the user-defined cut-off was not exceeded the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, is remote.

• Brand Name: SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US)
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): STOCKERT GMBH; boetzinger strasse 31; freiburg, b-w D-791 11; GM D-79111
• MDR Report Key: 15567918
• Report Number: 2029046-2022-50011
• Device Sequence Number: 14942202
• Product Code: LPB
• UDI-Device Identifier: 04260166371093
• UDI-Public: 04260166371093
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2022
• Report Date (Section F): 09/12/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/09/2022
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: CARTO 3 SYSTEM; OCTARAY; SMARTABLATE GENERATOR; SOUNDSTAR CABLE; SOUNDSTAR CATHETER
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Male