MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SOUNDSTAR ECO SMS 8F CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Catalog Number	10439011
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	06/18/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation with a soundstar catheter, and the patient experienced cardiac perforation that required pericardiocentesis and open-heart surgery, however the patient died.During an afib case, a perforation of the right ventricular outflow tract (rvot) was noticed within the first 20 minutes of the procedure.There was a drop in blood pressure on the patient and a pericardial effusion was confirmed by intracardiac echocardiogram (ice).The medical intervention provided was a pericardiocentesis and the patient was taken into open heart surgery.The patient was not stable.The physician believed the perforation was from the soundstar catheter during imaging since it was in the rvot where the perforation was discovered.The event occurred during initial ice imaging, during the first 15 minutes of the procedure.No transseptal puncture was performed.No ablation was performed.The outcome was death.The cause of death was cardiovascular failure during surgery that day to repair the perforation.(b)(4).
Additional Manufacturer Narrative
D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.Manufacturer's ref.No: (b)(4).

• Brand Name: SOUNDSTAR ECO SMS 8F CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive; suite 200; irvine CA 92618
• MDR Report Key: 19798807
• Report Number: 3023245-2024-00037
• Device Sequence Number: 15334714
• Product Code: OBJ
• UDI-Device Identifier: 10846835008852
• UDI-Public: 10846835008852
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2024
• Report Date (Section F): 07/11/2024

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 Catalogue Number: 10439011
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/12/2024
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 83 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/11/2024