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

Catalog Number D139701

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762)

Event Date 08/24/2023

Event Type  Injury  

Manufacturer Narrative

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.E1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster inc.'s reference number: (b)(4) has two reports: (1) manufacture report number#: 2029046-2023-02138 for product code unk_carto vizigo sheath (carto vizigo¿ 8.5f bi-directional guiding sheath).(2) manufacture report number#: 139 product code: d139701 (ngen pump, eu configuration).

Event Description

It was reported that a patient underwent an atypical flutter ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath and ngen pump, eu configuration and the patient experienced air embolism and cardiac arrest that required cardiopulmonary resuscitation (cpr) and prolonged hospitalization.It was reported that during use of bwi products, in ablation phase of the procedure, the patient suddenly lost blood pressure.They had to do manual compression to stabilize the patient.There was a 10 minutes delay and the case was completed.The physician thought it might have been due to a potential air embolism.Additional information was later receive indicating the physician's opinion on the cause of the adverse event was a hypothesis of an air embolism, but he is not completely sure.All catheters were removed before they started resuscitation.The patient¿s outcome was reported as improved.The patient was awake when she was sent to rikshospitalet.Patient required prolonged hospitalization for follow-up.A transseptal puncture was performed with an abbott - brk1 needle.Ablation had already been was performed prior to noting the adverse event.An there was no evidence of steam pop.Thermocool smarttouch sf catheter was used.The irrigated catheter was used with flow settings set to low: 15 ml/min high: 30 ml/min.The correct catheter settings were selected on the generator and the pump switched from low to high flow during ablation.No error messages observed on bwi equipment during the procedure.Force visualization features used include graph, dashboard, vector and visitag.Parameters for stability used were: maximum distance change: 5 mm, minimum time: 3 s, force over time (fot): 25%, min force: 3 g, tag size: 2, tag index: low: 380, high: 500.Color options used included tag index.Based on clinical review, this adverse event is being captured as an air embolism under the carto vizigo¿ 8.5f bi-directional guiding sheath and ngen pump, eu configuration.The hypotension and cardiac arrest have various etiologies, but since pericardial effusion/cardiac tamponade is not confirmed and based on the fact that the physician suspected air embolism, it can be clinically concluded that air embolism is the root cause of the cardiac arrest.

Manufacturer Narrative

It was reported that a patient underwent an atypical flutter ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath and ngen pump, eu configuration and the patient experienced air embolism and cardiac arrest that required cardiopulmonary resuscitation (cpr) and prolonged hospitalization.It was reported that during use of bwi products, in ablation phase of the procedure, the patient suddenly lost blood pressure.They had to do manual compression to stabilize the patient.There was a 10 minutes delay and the case was completed.The physician thought it might have been due to a potential air embolism.Additional information was later receive indicating the physician's opinion on the cause of the adverse event was a hypothesis of an air embolism, but he is not completely sure.All catheters were removed before they started resuscitation.The patient¿s outcome was reported as improved.Device evaluation details: the device evaluation was completed on (b)(6) 2024.No issues that could be related to the reported event description were found; however, the pump door was found damaged and it was replaced.The damaged door was not initially reported so it may have broken during pump shipment.In addition, if the door gets damaged the door sensor will not allow it to start the pump.A device history record evaluation was performed for the finished device number, and no internal action 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.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: locking mechanism (g06004) were selected as related to the issue door damage identified by bwi pal.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer's reported adverse event.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: 17786366
• MDR Text Key: 323893258
• Report Number: 2029046-2023-02139
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D139701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ABBOTT BRK1 NEEDLE.; CARTO 3 SYSTEM.; NGEN RF GENERATOR.; UNK_CARTO VIZIGO SHEATH.; UNK_SMART TOUCH BIDIRECTIONAL SF.
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening