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

Catalog Number SEE H10

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Low Blood Pressure/ Hypotension (1914); Ischemic Heart Disease (2493); Thrombosis/Thrombus (4440)

Event Date 11/29/2023

Event Type  Injury  

Event Description

It was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a decanav electrophysiology catheter and patient experienced elevated st, decreased blood pressure and thrombosis requiring medical intervention and prolonged hospitalization.It was initially reported that the carto 3 system was displaying error 7: current leakage error.When the sheath was disconnected the error cleared.To troubleshoot the cable was replaced without resolution.The sheath was replaced, the issue was resolved, and the procedure was continued.The current leakage error was the one that pops up saying current error in a large box across the screen and we lose catheter visualization on all catheters, and they would have to hit the blue button at the bottom to close that window and continue the study.The error was instant as soon as we plugged in, there was no noise.The customer¿s reported current leakage error is not considered to be an mdr reportable malfunction since this issue is highly detectable and requires adjusting system components to continue with the procedure.Devices may require reset or replacing but cannot be used on the patient.Patient safety is unaffected by this issue.Then the patient experienced st elevations and low blood pressure for about a minute or two and the procedure was cancelled.The caller stated that the decanav, soundstar, and the vizigo sheath were the only bwi products in the body at the time of the procedure.The physician's opinion on cause is the patient's condition as it's possible that crossed via patent foramen ovale (pfo) with baylis needle and knocked a clot loose inside that area.A code was called, pressors given, temporary pacing in the ventricles and clot resolved in a minute or so after the st elevation.Patient required an overnight stay in intensive care unit (icu) and reported to have fully recovered.No rf ablation was performed.The event is being reported against the decanav electrophysiology catheter as it is used in direct contact with cardiac tissue for mapping and stimulating (pacing) purposes.

Manufacturer Narrative

Device investigation details: available information indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because 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.D4.Catalog should be: unk_c3 webster decapolar with auto id - fixed.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: 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: 18450445
• MDR Text Key: 332172457
• Report Number: 2029046-2024-00075
• Device Sequence Number: 1
• Product Code: DRF
• 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: Other
• Type of Report: Initial
• Report Date: 01/04/2024

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: SEE H10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/05/2024
• 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: 8.5F SHEATH WITH CURVE VIZ MDC; BAYLIS NEEDLE; CARTO 3 SYSTEM; UNKNOWN CABLE; UNK_SOUNDSTAR
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention