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

Catalog Number	D139702
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a ngen pump, us configuration and bubbles were discovered in the tubing.During the study, it was noticed that bubbles were coming through the tubing.The tubing was flushed and the issue did not resolve.The ablation catheter was replaced and the issue did not resolve.The patient¿s vitals remained steady but the patient has not awakened yet.It is unknown is the patient has any symptoms at this time.Multiple attempts have been made to gain clarification and additional information about this event with no response.Should any new information be obtained it will be assessed and processed accordingly.
Additional 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).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a ngen pump, us configuration and bubbles were discovered in the tubing.During the study, it was noticed that bubbles were coming through the tubing.The tubing was flushed and the issue did not resolve.The ablation catheter was replaced and the issue did not resolve.The patient¿s vitals remained steady but the patient has not awakened yet.It is unknown is the patient has any symptoms at this time.Device evaluation details: it was reported service was declined since no further information was provided.A device history record evaluation was performed for the finished device number, and no internal action related to the reported condition were identified.The issue could not be attributed to the manufacturing process.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 ref.# (b)(4).

• Brand Name: NGEN PUMP, US CONFIGURATION
• Common Device Name: 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: 18837772
• Report Number: 2029046-2024-00726
• Device Sequence Number: 18002012
• Product Code: LPB
• UDI-Device Identifier: 10846835017472
• UDI-Public: 10846835017472
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P990071/S037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D139702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8.5 FR IRE CATHETER; 8.5 FR IRE CATHETER; CARTO 3 SYSTEM; UNKNOWN GENERATOR; UNKNOWN TUBING
• Patient Sex: Unknown