BREELIB INHALATION SYSTEM
Report
- Report Number
- 3008702754-2023-05995
- Event Type
- Malfunction
- Date Received
- March 25, 2024
- Date of Event
- November 2, 2023
- Report Date
- March 20, 2025
- Manufacturer
- VECTURA GROUP LTD
- Product Code
- CAF
- PMA / PMN Number
- K142059
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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.
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.
THE INCIDENT WAS REPORTED TO THE MANUFACTURER (VECTURA) BY THE DISTRIBUTOR (B)(4), WITH REF NO. (B)(4) ON 10-NOV-2023 CONCERNING THE BREELIB INHALATION SYSTEM. (B)(4) AND VECTURA HAVE A CO-PARTNER RELATIONSHIP WHERE THE BREELIB MEDICAL DEVICE (MANUFACTURED BY VECTURA) IS SUPPLIED BY (B)(4) 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 (B)(6) WITH A 51-YEAR-OLD FEMALE PATIENT. INITIAL INFORMATION THAT WAS REPORTED THROUGH THE CIOMS FORMS RELATING TO THE EVENT RECEIVED BETWEEN (B)(6) 2024 INDICATED THAT DURING THE PERIOD FROM 01-NOV-2015 TO (B)(6) 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)(6) 2023. ON 02-NOV-2023, THE PATIENT EXPERIENCED OPERATIONAL ISSUES WITH THE DEVICE AND TREATMENT WAS SUSPENDED ON (B)(6)2023. ON (B)(6) 2023, THE PATIENT REPORTED THAT SHE HAD NOT ADMINISTERED INHALATION SESSIONS FOR 23 DAYS DUE TO A FAULTY DEVICE. ON (B)(6) 2023, (B)(4) 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)(6) 2023, THE PATIENT HAD REPORTED THAT SHE HAD NOT BEEN ADHERING TO HER VENTAVIS (ILOPROST) TREATMENT SINCE THE BREELIB DEVICE HAD A FAILURE. AT THE TIME OF THIS REPORT THE INCIDENT DID NOT MEET THE CRITERIA FOR REPORTING. IN A FOLLOW-UP CIOMS I FORM RECEIVED ON (B)(6) 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 THERAPIES ARE UNLISTED IN THE VENTAVIS SMPC AND ARE NOT ACKNOWLEDGED EVENTS IN THE BREELIB IFU - THEY INDICATE WORSENING OF THE PATIENT'S PAH SYMPTOMS. THE CLINICAL OUTCOMES OF DECOMPENSATION AND DEPENDENCE ON 24 HOURS OXYGEN THERAPY WERE ASSESSED AS SERIOUS IN NATURE AND MEETING THE DEFINITION OF SERIOUS INJURY PER 21CFR 803.3, BY VECTURA. AS THE DEVICE INVOLVED IN THE EVENT HAD NOT BEEN RETURNED FOR INVESTIGATION, AN INITIAL MEDWATCH FORM HAD BEEN SUBMITTED TO THE FDA ON 25-MAR-2024 AS THE INCIDENT APPEARED TO MEET THE CRITERIA FOR REPORTABILITY. WITHIN THIS REPORT, THE LIKELY ROOT CAUSE OF THE ISSUE WAS HIGHLIGHTED 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. ON 18-JUL-2024, THE DEVICE INVOLVED IN THE EVENT HAD BEEN RETURNED TO VECTURA FOR INVESTIGATION AND INVESTIGATION REVEALED SIGNS OF LIQUID INGRESS INTO THE DEVICE WITH RESULTANT DAMAGE TO ELECTRONIC COMPONENTS IN THE DEVICE, ATTRIBUTABLE TO USE ERROR - EXHALATION INTO THE DEVICE (FAILURE TO FOLLOW CORRECT INHALATION TECHNIQUE OUTLINED IN THE IFU). IN LIGHT OF THE FINDINGS FROM THE INVESTIGATION, IT HAS BEEN DETERMINED THAT THERE IS NO CAUSAL LINK BETWEEN THE DEVICE AND REPORTED CLINICAL OUTCOME. AS SUCH, THE EVENT NO LONGER MEETS THE CRITERIA FOR REPORTING. 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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5114 | BREELIB INHALATION SYSTEM | BREELIB | CAF | VECTURA GROUP LTD | BREELIB STARTER PACK LAT1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Female | Other| R | VENTAVIS NEBULISER SOLUTION, 6DF, INHALATION| VENTAVIS NEBULISER SOLUTION, 6DF, INHALATION |