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

Catalog Number D139704

Device Problem Failure to Pump (1502)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure which included that use of a qdot micro¿ catheter and a ngen pump.During superior vena cava (svc) ablation with qdot micro catheter, the power was only 3w at the 25w power setting and the irrigation was still 4cc.The same behavior was observed when the power was set to 36w.The issue was resolved by replacing the catheter to a new one.After that, the procedure was successfully completed.The procedure was completed without patient consequence.Additional information was received which indicated that the most suspected device for the flow/irrigation issue is the catheter.The issue was noted during the use of the device on patient.On 01-apr-2024, additional information was received which indicated that there was no error noted from the irrigation pump.The correct catheter setting was selected on the generator.However, the ngen pump was not switching from ¿low¿ to ¿high¿ flow during ablation.The irrigation issue was resolved by replacing the catheter with a new one.With the additional information received, the issue with the ngen pump is now considered mdr reportable with an awareness date of 01-apr-2024.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6) 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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2024-01282 for product code d139501 (qdot micro catheter) (2) for product code d139704 (ngen pump, japan configuration).

• Brand Name: NGEN PUMP, JAPAN 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: 19128948
• MDR Text Key: 341166728
• Report Number: 2029046-2024-01283
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D139704
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2024
• 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: NGEN GENERATOR; QDOT MICRO, BI, TC, D-D