MAUDE Adverse Event Report: VECTURA GROUP LTD. BREELIB INHALATION SYSTEM

Model Number BREELIB STARTER PACK LAT1

Device Problem Failure to Deliver (2338)

Patient Problem Pulmonary Hypertension (4460)

Event Type  Injury  

Manufacturer Narrative

The suspect device in this report, breelib is not 510k cleared for use in the us.This case is being submitted to the fda as 'breelib' is a similar medical device to the 510k cleared fox mobile device.Neither the fox mobile or breelib are currently distributed in the us.

Event Description

The incident was reported to the manufacturer (vectura) by the distributor (bayer), with ref no.Co-bayer (b)(4) on 10-nov-2023 concerning the breelib inhalation system.Bayer and vectura have a co-partner relationship where the breelib medical device (manufactured by vectura) is supplied by bayer to patients to use with ventavis (iloprost) therapy for pulmonary arterial hypertension (pah) management in the eu and latin american markets.Breelib inhalation system is not 510k cleared.The report is being submitted to the us fda as the breelib device is a similar device to the 510k cleared fox mobile device.The case concerns an incident that occurred in colombia with a 51-year-old female patient.Initial information that was reported through the cioms forms relating to the event received between january and february 2024 indicated that during the period from (b)(4) 2015 to (b)(4) 2023 a patient was prescribed and received ventavis (iloprost) at an unspecified dose six times a day.A breelib nebulizer device was used by the patient from (b)(4) 2023 to (b)(4) 2023.On (b)(4) 2023, the patient experienced operational issues with the device and treatment was suspended on (b)(4) 2023.On (b)(4) 2023, the patient reported that she had not administered inhalation sessions for 23 days due to a faulty device.On (b)(4) 2023, bayer patient support program (psp) reported to have made a visit to the patient's home where failure of the device was confirmed, and parts (consumables) were changed.On (b)(4) 2023, the patient had reported that she had not been adhering to her ventavis (iloprost) treatment since the breelib device had a failure.Review and analysis of the information received indicated that the incident did not meet the criteria for reporting.In an amended cioms form received on 29-feb-2024, it was reported that on an unknown date, the patient experienced pulmonary hypertension (decompensation) and was dependent on oxygen 24 hours a day.Pulmonary hypertension decompensation and dependence on 24-hour oxygen therapy are unlisted in the ventavis smpc and are not acknowledged events in the breelib ifu.The clinical outcomes of decompensation and dependence on 24 hours oxygen therapy was assessed as serious in nature and meeting the definition of serious injury per 21cfr 803.3, by vectura.The device involved in the event had been discarded by the patient and had not been returned to vectura for investigation.Quality investigation into the incident was based on review of patient reported information for this case, versus any potentially similar complaints (using key word searching of vectura records) and review of the device history record.The investigation revealed that all units passed the functional tests before release to the market.The investigation concluded that the likely root cause of the device malfunction was use error (potential liquid ingress into the device resulting in malfunction).A full investigation of the actual device would be required to confirm this hypothesis and the alleged device malfunction.At the time of this report, the complaint could not be confirmed.As the patient had reported that due to the lack of the device she has not been able to have continuity of the treatment so the disease had progressed and as vectura has been unable to definitively rule out a causal/ contributory link between the alleged device issue and the clinical outcome, it has been determined that the event meets the minimum criteria for reporting based on the information available to-date.Breelib¿ is not designed for emergency and life support use.The breelib risk management file considers that chronic missed doses can result in injury or impairment which may require professional medical intervention.Ventavis® is administered using the breelib between 6- 9 times per day depending upon individual patient need and tolerability to ventavis®.Ventavis® is not first line therapy for pah, which is a progressive, incurable disease that will eventually lead to right heart failure and death.Ventavis® improves the clinical course of pah but can only delay disease progression.Ventavis® is unlikely to be used as a monotherapy for pah, although no details of concomitant medication have been provided for this case.

• Brand Name: BREELIB INHALATION SYSTEM
• Type of Device: BREELIB
• Manufacturer (Section D): VECTURA GROUP LTD.; one prospect west; chippenham, wiltshire SN14 6FH; UK SN14 6FH
• Manufacturer (Section G): VECTURA GROUP LTD.; one prospect west; chippenham, wiltshire SN14 6FH; UK SN14 6FH
• Manufacturer Contact: sally du toit ; one prospect west; chippenham, wiltshire SN14 -6FH ; UK SN14 6FH
• MDR Report Key: 18970884
• MDR Text Key: 338554732
• Report Number: 3008702754-2023-05995
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K142059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BREELIB STARTER PACK LAT1
• Device Catalogue Number: 08CD1046
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2023
• 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: VENTAVIS NEBULISER SOLUTION, 6DF, INHALATION
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female