MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECANAV ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number UNK_C3 CS REFSTAR - DEFLECTABL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 04/03/2024

Event Type  Injury  

Manufacturer Narrative

Since no device has been received for analysis, 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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2024-01395 for product code unknown (carto vizigo¿ 8.5f bi-directional guiding sheath) (2) mfr # for product code unknown (decanav electrophysiology catheter).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia ablation which included the use of a carto vizigo¿ 8.5f bi-directional guiding sheath and a decanav electrophysiology catheter, and the patient experienced cardiac tamponade that required pericardiocentesis and prolonged hospitalization.They noticed a pericardial effusion after the transseptal.However, they do not believe that it was caused by the transseptal.They were done mapping in the lv (left ventricle).The effusion was confirmed by the soundstar.The medical intervention provided to the patient was a pericardiocentesis.The patient's last known status was reported as stable and spent the night in the intensive care unit (icu) and was getting the drain taken out at the time of the call.They had a thermocool® smart touch® sf (stsf) catheter, "although it was not used", it was in the body at one point; however, it was not in the body when the effusion was noticed, and no ablation had taken place.They also used a soundstar catheter, a decanav catheter and a vizigo sheath for the procedure.Additional information received indicated that the adverse event was discovered during use of bwi products (uls and mapping), no ablation performed.The physician¿s opinion on the cause of this adverse event was that it was procedure related, prior to or during transseptal.Suspected from transseptal phase or pre-transseptal due to extremely challenging and tilted patient-specific anatomy.Suspected from tap that the perforation was anterior.No error messages during the procedure.There was no evidence of steam pop.The correct catheter settings were selected on generator.Patient fully recovered but stayed an additional night in the icu.

• Brand Name: DECANAV ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 19209599
• MDR Text Key: 341365708
• Report Number: 2029046-2024-01396
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008791
• UDI-Public: 10846835008791
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_C3 CS REFSTAR - DEFLECTABL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NGEN RF GENERATOR, US; THMCL SMTCH SF BID, TC, D-F; UNK BRK TRANSSEPTAL NEEDLE; UNK_CARTO VIZIGO SHEATH; UNK_SOUNDSTAR
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female