MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NGEN PUMP; 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	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a ngen pump and there were bubbles in the irrigation tubing during the procedure that were noticed by the physician but the ngen pump never alerted that there were bubbles detected.The tubing was flushed and the tubing and the pump sensor "looked good".When bubbles were noticed, the catheter was removed from the patient¿s body and flushed.There was no adverse event reported.
Additional Manufacturer Narrative
The product analysis lab received the device for evaluation.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 ref.No: (b)(4).
Additional Manufacturer Narrative
On 9-sep-2024, the product investigation was completed.D4 primary udi number has been updated to (b)(4).Device evaluation details: it was reported that there were bubbles in the irrigation tubing during the procedure that were noticed by the physician but the ngen pump never alerted that there were bubbles detected.No failure was found with the device.A device history record evaluation was performed for the finished device number (b)(4), and no internal actions related to the reported condition were identified.All devices are manufactured, inspected, and released to approved specifications as part of johnson & johnson medtech'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
• 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: 19605828
• Report Number: 2029046-2024-02066
• Device Sequence Number: 6520811
• Product Code: LPB
• UDI-Device Identifier: 10846835017472
• UDI-Public: (01)10846835017472(11)231011(21)111023-103
• Combination Product (Y/N): N
• 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): 09/10/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2023
• 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: CARTO 3 SYSTEM; CARTO3 EXTERNAL REFPATCH 6PACK; NGEN RF GENERATOR, US; UNK_SMARTABLATE PUMP TUBING
• Patient Sex: Unknown