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

Catalog Number D139701

Device Problem Failure to Sense (1559)

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

Event Date 12/07/2022

Event Type  malfunction  

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 ref.# (b)(4).

Event Description

It was reported that a patient underwent an pulmonary vein isolation(pvi) ablation procedure with a ngen pump, eu configuration and an issue of undetected air bubbles occurred.It's been reported there was an issue with the pump loaner.They had a bubble in the tubing and they made the tube air free but then had a bubble again.They even got a bubble behind the bubbles sensor but no error message.They made the tube air free again and someone was checking if there was bubble while they were finishing the procedure.There was no delay and the case was completed.There were no patient consequences.

Manufacturer Narrative

On 28-feb-2023, additional information was received which included the facility contact.As such, the appropriate fields in section e.Initial reporter have been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an pulmonary vein isolation(pvi) ablation procedure with a ngen pump, eu configuration and an issue of undetected air bubbles occurred.It's been reported there was an issue with the pump loaner.They had a bubble in the tubbing and they made the tube air free but then had a bubble again.They even got a bubble behind the bubbles sensor but no error message.They made the tube air free again and someone was checking if there was bubble while they were finishing the procedure.There was no delay and the case was completed.There were no patient consequences.Device evaluation details: the service record concluded the ngen pump, eu configuration is non-repairable, therefore, the device was replaced to solve the customers problem.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.Note: h6.Component code of ¿appropriate term/code not available (g07002)¿ was used since no singular component was determined to have malfunctions.The entire unit was replaced.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#(b)(4).

Manufacturer Narrative

On 6-jun-2023, additional information about the service and repair of this device was received.It was clarified that the device was received for repair at the service center and several tests were performed of which included generating bubbles intentionally to test the bubble sensor functionality.It was determined that the issue occurred due to a defective pump head.The unit was replaced to solve the problem.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: 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: 16068095
• MDR Text Key: 308528929
• Report Number: 2029046-2022-03254
• 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,Followup,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• 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: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN TUBING.