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

Catalog Number	UNK_SOUNDSTAR
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	08/15/2023
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.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib)-persistent ablation procedure that included a soundstar® eco diagnostic ultrasound catheter.The patient experienced cardiac perforation that required prolonged hospitalization.Two weeks after an afib-persistent case, the patient returned to the hospital and was admitted for a cardiac tamponade.The patient had come back to the hospital before complaining of pericarditis according to the physician.They ordered an echocardiogram (echo) and it was clear and the patient was sent home.The patient returned complaining of more chest pain and they did a transthoracic echo and a cardiac tamponade was shown.The medical intervention provided was a pericardiocentesis and 1 liter of fluid was removed.The patient was reported to be in stable condition.It was also reported that the patient is diabetic and on dialysis.On the day of the procedure, the international normalised ratio (inr) was 2.3.On the day when the patient came into the hospital for the same issue, the inr was 3.1 and yesterday, after getting admitted, the inr was 3.6.They also saw a little fibrosis in the interior portion of the intravenous (iv), so the physician thought it could have been a small perforation with intracardiac echocardiography (ice) in the right ventricle (rv) for possible post effusion.It was later reported that the fibroid area was anterior right ventricle.The physician used the power on the generator set to 50w and targets 425 sharepoint values for all of his passes.There was nothing unusual on the day of the procedure.The physician did not say if there was a malfunction, best guess was most likely caused by going into the right ventricle with cartosound catheter.Patient has fully recovered.The patient went home on the same day of procedure.Patient returned two weeks later and was hospitalized, length of stay unknown.Single transseptal was performed.Versa cross wire was used for transseptal.Flow settings of irrigated catheter was: 2ml/min mapping ¿ 8ml/min ¿ 15ml/min.The correct catheter settings were selected on generator.Pumped switched from low to high flow during ablation.There was no evidence of a steam pop.No known error messages observed on bwi equipment during the procedure.Force visualization features used were: graph, dashboard, vector, visitag.Parameters for stability were: 2 mm stability, 3 secs, 25% @3gm.No additional filter was used with the visitag.No color options were used.Confirmation was received that a soundstar ice catheter was used.Perforation was confirmed and thought was that the soundstar was most likely the reason.This event is being reported under the soundstar ice catheter as the perforation was in the right ventricle (rv), it is less likely that the adverse event happened due to the ablation catheter during applications in the left atrium (la).
Additional Manufacturer Narrative
On 18-nov-2023, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the 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.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): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17826019
• Report Number: 2029046-2023-02172
• Device Sequence Number: 6138317
• Product Code: OBJ
• UDI-Device Identifier: 10846835000153
• UDI-Public: 10846835000153
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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): 12/15/2023

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 Catalogue Number: UNK_SOUNDSTAR
• 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: 08/29/2023
• Supplement Date Received by Manufacturer: 11/18/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: THMCL SMTCH SF BID, TC, D-F; UNK GENERATOR; UNK_CARTO 3
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Sex: Male
• Patient Weight: 82 KG