MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NGEN PUMP, EU CONFIGURATION

Catalog Number D139701

Device Problem Decreased Pump Speed (1500)

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

Event Date 08/23/2023

Event Type  malfunction  

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

Event Description

It was mentioned in the manufacturing reference number (b)(4).(manufacturer report number: 2029046-2023-02111) that this was a recurring issue.An investigation was performed to determine if there was an existing manufacturer reference number for the reported recurring issue.Since we were unable to determine if there is an existing manufacturer reference number and it was assessed as a reportable malfunction, we have made the decision to create a related manufacturer reference number under (b)(4)(manufacturer report number: 2029046-2023-02112) to conservatively report the recurring issue.It was reported that a patient underwent an atrial fibrillation (afib) procedure with a ngen pump, eu configuration and low flow without an error message issue occurred.No warning of low flow at the generator while the bottle was empty.They tested after the procedure.Used a new bottle.The generator was saying it was 148ml.They then checked manually and seen it was only 94 ml.They needed to check manually the bottle to finish the procedure.The procedure was completed.No patient consequence.Five minute delay.It's been mentioned they had this issue since they received the pump.The low flow without an error message was assessed as mdr reportable.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a ngen pump, eu configuration and no warning of low flow at the generator while the bottle was empty.The investigation was completed on 12-feb-2024.The unit was returned to the manufacturer for evaluation.It was determined that the error of the complaint could not be confirmed.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported complaint condition were identified.All devices are manufactured, inspected, and released to approved specifications as part of biosense webster's quality process.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: NGEN PUMP, EU CONFIGURATION
• Type of Device: NGEN PUMP
• 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: 17769072
• MDR Text Key: 323713530
• Report Number: 2029046-2023-02112
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P990071/S037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D139701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2022
• 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 RF GENERATOR; UNK_SMART TOUCH BIDIRECTIONAL