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

Model Number	10439072
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial flutter left (l-afl) ablation procedure with a soundstar® eco diagnostic ultrasound catheter and suffered a cardiac tamponade (ct) requiring pericardiocentesis and prolonged hospitalization.It was reported that during "2 hours post-op" from this case, it was discovered with a ¿tte post-ablation echo" while in recovery, that the patient had suffered a pericardial effusion (pe).The patient's effusion was then "tapped and drained" and 500 cc of fluid was removed from the patient.The patient was reported as stable and did not need surgery.This was not a part of any study.The biosense webster inc.(bwi) representative stated that they used a 10 fr soundstar catheter, a smart touch sf (stsf) ablation catheter, a vizigo sheath, and a pentaray in the case.However, none of the devices are available for return due to the injury being discovered "2 hours post-op".The physician did not state what they believe the source of the injury to be.It was discovered post use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that it was procedure related.Outcome of the adverse event was improved.The patient required extended hospitalization because of the adverse event.Transseptal puncture was performed, needle details unknown.Prior to noting the pe or ct, ablation was performed.There was no evidence of steam pop.Irrigated catheter was used in the event, the flow setting was 2, 8, 15, normal stsf settings.Correct catheter settings were selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.Force visualization features used were dashboard, vector and visitag.Visitag module was used, parameters for stability used were 3s, 3mm, 25% above 3g.Additional filter used with the visitag was respiratory adjustment.Tag index was used.
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).

• 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): SIEMENS LTD. SEOUL; venture bldg 2, office 112 601; pohang technopark, jigok-dong; gyeongbuk 790-8 34; KS 790-834
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16710197
• Report Number: 2029046-2023-00771
• Device Sequence Number: 14972400
• Product Code: OBJ
• UDI-Device Identifier: 10846835008845
• UDI-Public: 10846835008845
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K112050
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2023

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: 10439072
• Device Catalogue Number: 10439072
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 04/10/2023
• 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: UNK TRANSSEPTAL NEEDLE.; UNK_CARTO 3.; UNK_CARTO VIZIGO SHEATH.; UNK_PENTARAY.; UNK_SMART TOUCH BIDIRECTIONAL SF.
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Male