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	12/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in progress, once completed a supplemental will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.(b)(4).
Event or Problem Description
It was reported that a female patient underwent a premature ventricular contraction (pvc) atrial fibrillation (afib) ablation procedure with a soundstar® eco diagnostic ultrasound catheter and the patient suffered a cardiac tamponade requiring pericardiocentesis.It was reported that during a pvc ablation case, pericardial effusion was noticed.The caller reported there were no visible signs on the patient.The pericardial effusion was confirmed by intracardiac echocardiography (ice).The caller reported that the medical intervention provided was a pericardiocentesis and 150ml of fluid was removed.Additional information was received indicating this adverse event was discovered during use of biosense webster products, during the mapping phase.No ablation was performed, as such, there was no steam pop.The physicians opinion is that he perforated with ice catheter.There was no malfunction of equipment.The patient¿s outcome from the adverse event is that it was improved.It is uncertain if the patient required extended hospitalization because of the adverse event, the patient was transferred to intensive care unit (icu) for observation.A smartablate generator was used during this case with the correct catheter settings selected.The flow setting for the pump were set per instructions for use (ifu), however, ablation has not been started.At a transseptal puncture was performed with a brk needle.No error messages were noted.Dashboard, vector, and visitag force visualization features were used.Parameters for stability used with visitiag were range 2.5, time 3sec, force over time (fot) 25%, however, ablation had not started.No additional filter was used with the visitag.Fti was the color option but no was ablation performed.Ablation catheter was inside body, but no ablation had been performed, only the soundstar® eco diagnostic ultrasound catheter has been used.The event will be reported against the the cardiac tamponade will be reported against the soundstar® eco diagnostic ultrasound catheter due to the ¿physicians opinion is that he perforated with ice, and no malfunction of equipment.".
Additional Manufacturer Narrative
It was reported that a female patient underwent a premature ventricular contraction (pvc) atrial fibrillation (afib) ablation procedure with a soundstar® eco diagnostic ultrasound catheter and the patient suffered a cardiac tamponade requiring pericardiocentesis.It was reported that during a pvc ablation case, pericardial effusion was noticed.The caller reported there were no visible signs on the patient.The pericardial effusion was confirmed by intracardiac echocardiography (ice).The caller reported that the medical intervention provided was a pericardiocentesis and 150ml of fluid was removed.Device investigation details: the device investigation has been completed which included performing a manufacturing record evaluation (mre).The manufacturing record evaluation performed for the finished device with lot number g4096973 identified no internal actions related to the reported complaint condition.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.However, if the product is received at a later date, the investigation will be updated as applicable.Based on the completed mre, the h4.Device manufacture date has been populated with 11/1/2022.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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): BIOSENSE WEBSTER INC (IRWINDALE); 15715 arrow highway; irwindale CA
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16190819
• Report Number: 2029046-2023-00106
• Device Sequence Number: 5971887
• Product Code: OBJ
• UDI-Device Identifier: 10846835008845
• UDI-Public: 10846835008845
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

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 Expiration Date: 10/31/2023
• Device Model Number: 10439072
• Device Catalogue Number: 10439072
• Device Lot Number: G4096973
• 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: 12/19/2022
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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: BRK TRANSSEPTAL NEEDLE; CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-US; THMCL SMTCH SF UNID, TC, D
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 53 KG