MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	SNDSTR10
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a soundstar® eco diagnostic ultrasound catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis.It was reported that during an ablation procedure with an octaray catheter, the patient sustained a pericardial effusion.This injury was discovered when a blood pressure drop was noticed in the patient.The injury was confirmed via the intracardiac echocardiography (ice) system with a soundstar® eco diagnostic ultrasound catheter.A pericardiocentesis was performed for medical intervention which resulted in 300 milliliters of fluid being removed from the patient.The patient is now stable.The physician believes the ice catheter went into the right atrial appendage and caused a perforation.Additional information was received.It was discovered during use of biosense webster inc.(bwi) products.Physician¿s opinion on the cause of this adverse event was bwi product malfunction and patient condition (anatomy).Pericardiocentesis was performed.Outcome of adverse event was fully recovered.Patient stayed overnight and was then discharged the next day.Transseptal puncture was performed, via a baylis versacross w/ fixed sheath and pigtail wire.No ablation was performed.No evidence of a steam pop.The event occurred during the mapping phase.Smart touch surround flow catheter was set to standard low flow setting.Correct catheter settings were selected on the generator.No error messages on carto 3 system.Force visualization features used were graph, dashboard and vector; visitag was set up, but no ablation was performed.Since it was reported that the physician believes the ice catheter went into the right atrial appendage and caused a perforation, the adverse event was assessed as mdr reportable under the soundstar® eco diagnostic ultrasound catheter.

• Brand Name: SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16391817
• Report Number: 2029046-2023-00312
• Device Sequence Number: 5592442
• Product Code: OBJ
• UDI-Device Identifier: 10846835000139
• UDI-Public: 10846835000139
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K070242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2023

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: SNDSTR10
• Device Catalogue Number: SNDSTR10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NON BWI-BAYLIS VERSACROSS FIXED SHEATH/PIGTAILWIRE; SMART TOUCH SURROUND FLOW CATHETER; SMARTABLATE GENERATOR KIT-US; UNKNOWN BRAND ICE SYSTEM; UNK_CARTO 3; UNK_OCTARAY NAV
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 65 KG