MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NGEN PUMP, EU CONFIGURATION; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D139701

Device Problems Failure to Sense (1559); Patient Device Interaction Problem (4001)

Patient Problems Tachycardia (2095); Ischemic Heart Disease (2493)

Event Date 01/24/2024

Event Type  Injury  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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).

Event Description

It was reported a patient underwent an atrial fibrillation (afib) cardiac ablation procedure with a ngen pump, eu configuration and patient experienced elevated st segment followed by ventricular tachycardia.In addition, a bubbles (undetected) issue.It was reported there's a functionality issue with the ngen pump, eu configuration.They were ablating with the irrigation catheter.During the procedure, there're flushing and the liquid bag has been empty and local technician came to replace it.He did not see any bubbles inside the distal part of the irrigation tubbing set, but after replacing the empty bag, he saw suddenly the st elevation within the patient ecg and afterward an arrhythmia vt happened but was not supposed to happen.Therefore, they had to cardiovert the patient.There was a 10-15 minute delay.Managed to complete the procedure with the issue.They thought that the bubbles had been introduced through the irrigation pump to the irrigation catheter.In addition, a current leakage error appeared.After disconnecting all the cables and reconnecting one by one, they identified the problem was the ablation catheter.At first, they replaced the cable but the leakage continued then the catheter was replaced and the procedure continued.No signal noise observed and no signal loss.The physician had ecg signals available to monitor the patient¿s heart rhythm.Additional information was received.Patient has fully recovered (no residual effects).The physician¿s opinion on the cause of this adverse event was product malfunction and procedure related.The current leakage error was assessed as non mdr reportable.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.The patient safety is unaffected by this issue.The bubbles (undetected) was assessed as a mdr reportable malfunction issue.The adverse event was assessed as a mdr reportable serious injury.

• Brand Name: NGEN PUMP, EU CONFIGURATION
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER, INC.; 560 cottonwood drive; milpitas CA
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18761383
• MDR Text Key: 336021721
• Report Number: 2029046-2024-00592
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P990071/S037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D139701
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; NGEN RF GENERATOR; THMCL SMTCH SF BID, TC, D-F; UNK CABLE; UNK IRRIGATION TUBING SET
• Patient Outcome(s): Required Intervention; Life Threatening