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

Catalog Number D139702

Device Problem Failure to Pump (1502)

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

Event Date 03/15/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a ngen pump and when the physician would immediately come back on radiofrequency (rf) during the 4 seconds post, the flow rates were not automatically adjusted.They will lower the post for a second time to continue the procedure.No adverse patient consequence was reported.

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.Manufacturer's reference number: (b)(4).

• Brand Name: NGEN PUMP, US 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: 19099622
• MDR Text Key: 340809801
• Report Number: 2029046-2024-01215
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835017472
• UDI-Public: 10846835017472
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990071/S037
• 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: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D139702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2023
• 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