MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SOUNDSTAR ECO GE 10F 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	02/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) biosense webster manufacturer's reference number (b)(4) has 2 reports.
Event or Problem Description
It was reported that a patient underwent a re-do afib cardiac ablation procedure with thermocool® smart touch® sf bi-directional catheter and soundstar eco ge 10f catheter.The patient experienced a cardiac tamponade requiring pericardiocentesis.It was reported that a perforation and cardiac tamponade occurred during a redo afib procedure.They reported that after performing 2 ablations, the patient's blood pressure dropped.The pericardial effusion was confirmed with intracardiac echocardiography (ice).The medical intervention provided was a pericardiocentesis and 750 ml of fluid was removed.The patient was reported to be in stable condition.It was suspected that the ice catheter or the webster coronary sinus (cs) catheter caused the perforation but that they were unsure.Additional information: outcome of the adverse event was fully recovered.Patient did not require extended hospitalization.Relevant tests/laboratory data- none.Other relevant history-50% ejection fraction, history of a fib.Generator information was a stockert smart ablate: g4c-5466-a.Other information: patient was 6 foot 2 inches.750 ml of blood was removed.Blood transfusion through iv was performed.Heparin was given after the transseptal puncture was performed.Act was taken and returned as 580.Transfusion puncture was performed with a baylis, versacross rf wire, catalog number unknown.2 ablations were performed.It is not believed that the ablations were the cause of the event.There was no evidence of steam pop.The event occurred during the ablation phase.The flow setting for the irrigated catheter was 15 ml/min, they were ablating with an stsf at 50 w.Correct catheter settings were selected on the generator.Pump switching from ¿low¿ to ¿high¿ flow during ablation.No error messages observed on biosense webster equipment during the procedure.Graph, dashboard, vector, visitag were used.Visitag module was used, parameters for stability used was 3 mm, 3 sec, 25% fot, 3 sec.No additional filter used with the visitag.Impedance drop, custom range 5 to 10 ohms was used.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.
Additional Manufacturer Narrative
On 2-jun-2023, the product investigation was completed.It was reported that a patient underwent a re-do afib cardiac ablation procedure with thermocool® smart touch® sf bi-directional catheter and soundstar eco ge 10f catheter.The patient experienced a cardiac tamponade requiring pericardiocentesis.It was reported that a perforation and cardiac tamponade occurred during a redo afib procedure.They reported that after performing 2 ablations, the patient's blood pressure dropped.The pericardial effusion was confirmed with intracardiac echocardiography (ice).The medical intervention provided was a pericardiocentesis and 750 ml of fluid was removed.The patient was reported to be in stable condition.It was suspected that the ice catheter or the webster coronary sinus (cs) catheter caused the perforation but that they were unsure.Device evaluation details: visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.Device history record was performed for the finished device g4092605 number, and no internal actions related to the reported complaint condition were identified.No malfunction was observed during the product analysis.No error messages were observed on biosense webster equipment during the procedure.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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 GE 10F 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: 16563286
• Report Number: 2029046-2023-00566
• Device Sequence Number: 5535147
• Product Code: OBJ
• UDI-Device Identifier: 10846835008845
• UDI-Public: 10846835008845
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2023

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: 08/04/2023
• Device Model Number: 10439072
• Device Catalogue Number: 10439072
• Device Lot Number: G4092605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 05/11/2023; 06/02/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 05/23/2023; 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2022
• 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: BAYLIS, VERSACROSS RF WIRE,; CARTO 3 SYSTEM; CARTO VISITAG MODULE; SMARTABLATE GENERATOR; THERMOCOOL SMARTTOUCH; UNSPECIFIED PUMP
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 117 KG