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

Catalog Number	10439236
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure using soundstar eco 8fg ultrasound catheter and decanav electrophysiology catheter.The patient experienced heart block that required implantation of temporary pacemaker.The patient developed transient heart block during the procedure.This occurred prior to any ablation and prior to transseptal access.Upon review of the study using the timeline feature, there were no catheters near the his/ atrioventricular (av) node.Prior to advancing the decanav and right ventricle (rv) quad catheters into the patient, there was right bundle branch block noted.The soundstar eco 8fg ultrasound catheter had already been advanced and was floating in the right atrium.After all the catheters were placed, a wire was advanced to the superior vena cava and the heart block was then noted.The physician is unsure how/why the heart block occurred.The patient was in af at the beginning of the procedure, so no av node interval measurements could be recorded.A temporary pacemaker was placed at this time.The patient was currently stable and intermittently in sinus rhythm, with a long pr interval.Biosense webster, inc.Products used was the webster quad, soundstar, and decanav.No ablation catheter had been in the body.Additional information was received.Physician's opinion on the cause of this adverse event was patient condition.Patient recovered.Other relevant medical history includes existing fascicular block.The adverse event was assessed conservatively reportable under both the soundstar eco 8fg ultrasound catheter and decanav electrophysiology catheter.

• Brand Name: SOUNDSTAR ECO 8F ULTRASOUND CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive; suite 200; irvine CA 92618
• MDR Report Key: 17990281
• Report Number: 3023245-2023-00024
• Device Sequence Number: 15275688
• Product Code: OBJ
• UDI-Device Identifier: 10846835008869
• UDI-Public: 10846835008869
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/22/2023
• Report Date (Section F): 10/23/2022

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 Expiration Date: 05/24/2024
• Device Catalogue Number: 10439236
• Device Lot Number: G9317217
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2023
• 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: 7FR DECAN,11P,D,2.4MMLE,282MM,UNK WEBSTER QUAD CAT
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/23/2022