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

Model Number M490008

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Air Embolism (1697)

Event Date 06/16/2023

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster inc.'s reference number pc-(b)(4) has two reports: (1) manufacture report number # 2029046-2023-01481 for product code d138502 (carto vizigo¿ 8.5f bi-directional guiding sheath - medium) (2) importer report number # (b)(4) product code m490008 (smartablate¿ system irrigation pump (us)).

Event Description

It was reported a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a smartablate¿ system irrigation pump (us) and the patient experienced an air embolism and medical intervention was required.It was reported that while doing the pulmonary vein isolation and toward the end of the procedure, the physician noticed bubbles inside the aorta.They reported that the patient's blood pressure dropped and heart rate slowed.The bubbles were confirmed with intracardiac echocardiography (ice).The physician performed heart cath maneuvers to determine where the bubbles originated from.The physician was unable to determine where the bubbles originated from during the procedure.The procedure was aborted.They were in the testing phase and that the therapeutic portion of the procedure was completed.The patient woke up, was breathing fine, and passed tests from the certified registered nurse anesthetist (crna) and nurses.The patient was sent to the emergency department to be evaluated per protocol.The patient was reported to be in stable condition.Post-procedure the physician determined that the bubbles had come from the pressure bag that was connected to the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.Additional information received indicated they performed a test after the case with the pump and bubble sensor and the equipment worked as intended.This adverse event was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event is that it was procedure related.The physician believes air got into the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.He speculated the most likely cause being from when he performed a catheter exchange.Intervention provided was that a heart cath was performed.The patient¿s outcome from the adverse event was reported as fully recovered (no residual effects).Patient required extended hospitalization because of the adverse event as they believe it is hospital protocol for the patient to remain overnight given an event occurring.Patient¿s medical history included an abg was performed (the results were all good).The patient did not exhibit any neurological symptoms since the procedure was completed.The patient was released from the hospital june 17, the day after the procedure.

• 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 Key: 17303454
• MDR Text Key: 319091329
• Report Number: 2029046-2023-50012
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 04260166371093
• UDI-Public: 04260166371093
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/20/2023,07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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: 06/16/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8.5F SHEATH WITH CURVE VIZ MDC; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male