BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREELIB INHALATION SYSTEM

    MDR report key: 19469381 · Received June 5, 2024

    Report

    Report Number
    3008702754-2024-06547
    Event Type
    Injury
    Date Received
    June 5, 2024
    Date of Event
    April 24, 2024
    Report Date
    August 13, 2024
    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

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IN THIS REPORT - BREELIB IS NOT 510K CLEARED FOR SALE IN THE US. THIS CASE IS BEING SUBMITTED TO THE FDA AS BREELIB IS CONSIDERED A 'SIMILAR DEVICE' TO THE 510K CLEARED FOX MOBILE. NEITHER BREELIB NOR FOX MOBILE ARE CURRENTLY SOLD IN THE US.

    Description of Event or Problem · 0

    THE INCIDENT WAS REPORTED TO THE MANUFACTURER (VECTURA) BY THE DISTRIBUTOR (BAYER), WITH REF NO. CO-BAYER 2024-024163/ (B)(4) AND VECTURA REFERENCE (B)(4), ON 10-MAY-2024 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 (B)(6) WITH A 57-YEAR-OLD FEMALE PATIENT. INITIAL INFORMATION THAT WAS REPORTED THROUGH THE CIOMS FORMS RELATING TO THE EVENT RECEIVED ON 10-MAY-2024 INDICATED THAT THE PATIENT HAD STARTED VENTAVIS THERAPY FOR MANAGEMENT OF THEIR PAH AT AN UNSPECIFIED DOSE AND FREQUENCY IN NOVEMBER 2022. FROM 19-NOV-2022 TO 24-APR-2024, THE PATIENT HAD RECEIVED VENTAVIS 20MCG/ML 6 INHALATIONS PER DAY. ON 24-APR-2024, 522 DAYS AFTER VENTAVIS 20MCG/ML INITIATION AND ON THE DAY OF ITS MOST RECENT USE, THE PATIENT HAD EXPERIENCED OPERATIONAL ISSUES WITH THE DEVICE (CODED AS 'DEVICE FAILURE' BY BAYER) AND MISSED TREATMENT(S). BOTH THE PTC AND THE CIOMS ONLY STATED THE FOLLOWING - 'PATIENT LEFT IT CHARGING BUT WHEN SHE PERFORMS NEBULISATIONS IT DOES NOT WORK'. THE CIOMS FORM CODED THIS DESCRIPTION TO 'DEVICE OPERATIONAL ISSUE'. NO FURTHER INFORMATION IS AVAILABLE. IT WAS REPORTED BY THE PATIENT'S RELATIVE THAT THE PATIENT EXHIBITED SIGNS OF CYANOSIS AND DYSPNOEA BUT NOT MEDICALLY CONFIRMED. BAYER HAD UPGRADED THE CASE TO 'SERIOUS, MEDICALLY SIGNIFICANT'. UPON INQUIRY, THE PATIENT STATED THAT SINCE 24-APR-2024, THEY HAVE NOT BEEN PERFORMING NEBULISATIONS OF THE MEDICATION DUE TO THE FAILURE OF THE DEVICE AND THAT CYANOSIS IS RELATED TO MISSING TREATMENT DUE TO DEVICE FAILURE. IN A FOLLOW-UP CIOMS RECEIVED BY VECTURA ON 19-MAY-2024, THE RELATIVE OF THE PATIENT REPORTED THAT THE PATIENT IS EXHIBITING SIGNS THAT ARE CONSISTENT WITH BOTH TYPES OF CYANOSIS I.E., PERIPHERAL AND CENTRAL, IN THE HANDS, FACE, FEET AND WHOLE BODY. PATIENT'S RELATIVE REPORTED THAT BEFORE EXPERIENCING THE DEVICE FAILURE, THE PATIENT HAD CYANOSIS AND DYSPNOEA, BUT NOT WITH THE FREQUENCY THAT THEY ARE EXPERIENCING RIGHT NOW DUE TO THE DEVICE FAILURE. IT IS NOT KNOWN IF THE PATIENT RECEIVED ANY ALTERNATE MEDICAL TREATMENT OR IF THEY ARE SELF-MEDICATED. IT WAS ALSO STATED THAT THE DYSPNOEA AND CYANOSIS ARE CONSTANT, AND THE PATIENT'S SYMPTOMS ARE NOT IMPROVING. THE PATIENT'S RELATIVE ALSO REPORTED THAT THE PATIENT HAS HEADACHE, CHEST PAIN, INFLAMMATION IN THE FEET UPPER AND LOWER LIMBS (ARMS AND FEET) AND INFLAMMATION IN THE FACE. THE PATIENT'S RELATIVE REPORTED THAT THE PATIENT HAS NOT BEEN HOSPITALIZED OR HAS HAD ANY INTERVENTION FOR THE SYMPTOMS EXPERIENCED. THE REPORTED CLINICAL OUTCOMES OF DYSPNOEA AND CYANOSIS (PERIPHERAL AND CENTRAL) WERE ASSESSED AS SERIOUS IN NATURE, BY VECTURA AND AS MEETING THE DEFINITION OF SERIOUS INJURY PER 21CFR 803.3. THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED TO VECTURA FOR INVESTIGATION AT THE TIME OF THIS REPORT. IT IS OUR UNDERSTANDING THAT THE DEVICE IS STILL IN THE PATIENT'S POSSESSION. EFFORTS ARE BEING MADE BY BAYER TO RETRIEVE THE DEVICE FROM THE PATIENT, FOR INVESTIGATION. QUALITY INVESTIGATION CONDUCTED INTO THIS INCIDENT TO-DATE HAS BEEN 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 THAT BELONG TO THE SAME BATCH AS THE DEVICE IN QUESTION HAD PASSED THE FUNCTIONAL TESTS BEFORE RELEASE TO THE MARKET. THE INVESTIGATION CONCLUDED THAT THE LIKELY ROOT CAUSE OF THE REPORTED 'DEVICE FAILURE' WAS USE ERROR (POTENTIAL LIQUID INGRESS INTO THE DEVICE DUE TO INCORRECT CLEANING TECHNIQUE). A FULL INVESTIGATION OF THE ACTUAL DEVICE WOULD BE REQUIRED TO CONFIRM THIS HYPOTHESIS AND THE ALLEGED DEVICE FAILURE. 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 AND HAS EXPERIENCED A SERIOUS CLINICAL OUTCOME 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, PER 21CFR803.3 (O). HOWEVER, THIS ASSESSMENT MAY CHANGE IF THE DEVICE WERE TO BE RETURNED TO VECTURA OR FURTHER INFORMATION IS RECEIVED FROM THE PATIENT, RELATIVE OR LOCAL PHYSICIAN ATTENDING EXPANDED ON THE CLINICAL IMPACT, FOR INVESTIGATION AND THE FINDINGS FROM THE INVESTIGATION CHALLENGE THE CURRENT ASSUMPTION REGARDING CAUSAL/ CONTRIBUTORY LINK BETWEEN THE ALLEGED DEVICE ISSUE AND THE REPORTED CLINICAL OUTCOME. 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 GENERALLY PRESCRIBED AS PART OF A TRIPLE THERAPY FOR PAH, ALTHOUGH NO DETAILS OF CONCOMITANT MEDICATION HAVE BEEN PROVIDED FOR THIS CASE.

    Description of Event or Problem · 0

    THE INCIDENT WAS REPORTED TO THE MANUFACTURER (VECTURA) BY THE DISTRIBUTOR ((B)(4)), WITH REF NO. (B)(4) AND VECTURA REFERENCE (B)(4), ON (B)(6) 2024 CONCERNING THE BREELIB INHALATION SYSTEM. BAYER 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. THE 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 57-YEAR-OLD FEMALE PATIENT. INITIAL INFORMATION THAT WAS REPORTED BY BAYER RELATING TO THE EVENT RECEIVED ON (B)(6) 2024 INDICATED THAT THE PATIENT HAD STARTED VENTAVIS THERAPY FOR MANAGEMENT OF THEIR PAH AT AN UNSPECIFIED DOSE AND FREQUENCY IN (B)(6) 2022. FROM (B)(6) 2022 TO (B)(6) 2024, THE PATIENT HAD RECEIVED VENTAVIS 20MCG/ML 6 INHALATIONS PER DAY. ON (B)(6)2024, 522 DAYS AFTER VENTAVIS 20MCG/ML INITIATION AND ON THE DAY OF ITS MOST RECENT USE, THE PATIENT HAD EXPERIENCED OPERATIONAL ISSUES WITH THE DEVICE (CODED AS 'DEVICE FAILURE' BY BAYER) AND MISSED TREATMENT(S). THE BAYER REPORTS ONLY STATED THE FOLLOWING - 'PATIENT LEFT IT CHARGING BUT WHEN SHE PERFORMS NEBULISATIONS IT DOES NOT WORK'. THE REPORT CODED THIS DESCRIPTION TO 'DEVICE OPERATIONAL ISSUE'. NO FURTHER INFORMATION WAS AVAILABLE. IT WAS NOTED FROM THE INITIAL CIOMS FORM THAT THE PATIENT'S RELATIVE REPORTED THAT THE PATIENT EXHIBITED SIGNS OF CYANOSIS AND DYSPNOEA BUT THIS HAD NOT BEEN MEDICALLY CONFIRMED. BAYER HAD UPGRADED THE CASE TO 'SERIOUS, MEDICALLY SIGNIFICANT'. UPON INQUIRY, THE PATIENT STATED THAT SINCE (B)(6) 2024, THEY HAVE NOT BEEN PERFORMING NEBULISATIONS OF THE MEDICATION DUE TO THE FAILURE OF THE DEVICE AND THAT CYANOSIS IS RELATED TO MISSING TREATMENT DUE TO DEVICE FAILURE. IN A FOLLOW-UP CIOMS RECEIVED BY VECTURA ON (B)(6) 2024, THE RELATIVE OF THE PATIENT REPORTED THAT THE PATIENT IS EXHIBITING SIGNS THAT ARE CONSISTENT WITH BOTH TYPES OF CYANOSIS I.E., PERIPHERAL AND CENTRAL, IN THE HANDS, FACE, FEET AND WHOLE BODY. THE PATIENT'S RELATIVE REPORTED THAT BEFORE EXPERIENCING THE DEVICE FAILURE, THE PATIENT HAD CYANOSIS AND DYSPNOEA, BUT NOT WITH THE FREQUENCY THAT THEY ARE EXPERIENCING RIGHT NOW DUE TO THE DEVICE FAILURE. IT WAS ALSO STATED THAT THE DYSPNOEA AND CYANOSIS ARE CONSTANT, AND THE PATIENT'S SYMPTOMS ARE NOT IMPROVING. THE PATIENT'S RELATIVE ALSO REPORTED THAT THE PATIENT HAS HEADACHE, CHEST PAIN, INFLAMMATION IN THE FEET UPPER AND LOWER LIMBS (ARMS AND FEET) AND INFLAMMATION IN THE FACE. THE PATIENT'S RELATIVE REPORTED THAT THE PATIENT HAS NOT BEEN HOSPITALIZED OR HAS HAD ANY INTERVENTION FOR THE SYMPTOMS EXPERIENCED. THE REPORTED CLINICAL OUTCOMES OF DYSPNOEA AND CYANOSIS (PERIPHERAL AND CENTRAL) WERE ASSESSED AS SERIOUS IN NATURE, BY VECTURA AND AS MEETING THE DEFINITION OF 'SERIOUS INJURY' PER 21CFR 803.3. AT THE TIME OF SUBMISSION OF THE INITIAL MEDWATCH FORM ON (B)(6), THE DEVICE INVOLVED IN THE EVENT HAD NOT BEEN RETURNED TO VECTURA FOR INVESTIGATION. THE QUALITY INVESTIGATION INTO THE INCIDENT WAS THEREFORE BASED ON REVIEW OF PATIENT REPORTED INFORMATION, REVIEW OF POTENTIALLY SIMILAR COMPLAINTS FOR DETERMINATION OF LIKELY ROOT CAUSE, AND REVIEW OF THE DEVICE HISTORY RECORD. HOWEVER, ON (B)(6), THE DEVICE INVOLVED IN THE EVENT WAS RETURNED TO VECTURA FOR INVESTIGATION. THE EVALUATION OF THE RETURNED DEVICE RESULTED IN THE FOLLOWING FINDINGS. FUNCTIONAL AND VISUAL INSPECTIONS WERE FIRST PERFORMED ON THE BASE UNIT, AND THE OUTCOMES ARE: 1. CONTAMINATION AND SIGNS OF CORROSION VISIBLE ON BOTH CONTACT PINS, CONTAMINATION OF MOUTHPIECE INLET CHANNEL AND SEAL, IN THE SIDE CLIPS AND IN MOUTHPIECE INDICATOR WINDOW. 2. THE BLUETOOTH DATA COULD BE READ. THERE WERE (B)(4) PATIENT USES IN TOTAL. FIRST PATIENT USE WAS (B)(6) 2023. LAST PATIENT USE RECORDED WAS (B)(6) 2024. DEVICE IS WITHIN MANUFACTURER'S WARRANTY. 3. THERE WERE 1600 ERROR CODES IN TOTAL. THE MAIN ERROR WAS 'INHALING IN THE EXHALATION PHASE' WITH 982 ERRORS RECORDED. THERE WERE ALSO 494 ERRORS RECORDED FOR 'TOO LOW INHALING PRESSURE'. 4. DEVICE SELF-TEST WAS PERFORMED USING GOLD NEBULISER HEAD AND FAILED - MOUTHPIECE LIGHT FLASHED ORANGE AND DEVICE SWITCHED OFF. BASE UNIT DID NOT RECOGNISE THE PRESENCE OF THE GOLDEN NEBULISER HEAD. THIS IS MOST LIKELY DUE TO CORROSION OF CONTACT PINS. 5. INITIAL INHALATION COULD NOT BE PERFORMED, DEVICE SWITCHES OFF. TESTING WAS DISCONTINUED. THE DEVICE CASING WAS OPENED, AND UNIT WAS DISASSEMBLED FOR VISUAL INSPECTION OF THE INTERNAL COMPONENTS. THE FOLLOWING OBSERVATIONS WERE MADE: 1. DUST BUILD UP OBSERVED ON AIR VENT SEPARATOR. 2. CONTAMINATION FOUND INSIDE ACU INLET AND INSIDE ACU SEAL. VISUAL INSPECTION PERFORMED ON THE MOUTHPIECE REVEALED SOME CONTAMINATION VISIBLE ON THE FILTER. VISUAL AND FUNCTIONAL INSPECTIONS WERE PERFORMED ON THE NEBULISER HEAD, AND THE OUTCOMES ARE: 1. MEMBRANE CONTAMINATION VISIBLE UNDER WHITE LIGHT UNDER MICROSCOPE, WITH MEDIUM MESH BLOCKAGE VISIBLE UNDER BLUE LIGHT UNDER MICROSCOPE. 2. INITIAL INHALATION WITH TEST BASE UNIT COULD BE PERFORMED. THE DELIVERED DOSE CALCULATED WAS 245.5 UL THAT IS WITHIN THE DELIVERED DOSE SPECIFICATION LIMITS OF 237.5 - 312.5 UL AND THE DELIVERY RATE CALCULATED WAS 0.18 ML / MIN THAT DOES NOT MEET THE DELIVERY RATE SPECIFICATION LIMITS OF 0.23 - 0.55 ML / MIN. 3. MESH BLOCKAGE AND OUT OF SPECIFICATION DELIVERY RATE IS MOST LIKELY DUE TO FAILURE TO WASH THE DEVICE AS PER IFU. BASED ON THE INVESTIGATION, IT IS CONCLUDED THAT THE REPORTED DEVICE MALFUNCTION IS LIKELY TO BE DUE TO THE LIQUID DAMAGE THAT CAUSED CORROSION TO THE BASE UNIT CONTACT PINS. THIS IS MOST LIKELY DUE TO PATIENT USE ERROR BY USING A WET NEBULISER HEAD, NOT IN ACCORDANCE WITH THE IFU. THE COMPLAINT IS THEREFORE NOT ATTRIBUTABLE TO THE DEVICE. IN LIGHT OF THE FINDINGS FROM THE EVALUATION OF THE RETURNED DEVICE, VECTURA HAS CONCLUDED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED CLINICAL OUTCOME. AS SUCH, THE EVENT NO LONGER MEETS THE DEFINITION OF A REPORTABLE EVENT, PER 21 CFR 803. 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 GENERALLY PRESCRIBED AS PART OF A TRIPLE THERAPY 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
    822592 BREELIB INHALATION SYSTEM BREELIB CAF VECTURA GROUP LTD. BREELIB STARTER PACK LAT1

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other VENTAVIS 20MCG/ML NEBULISER SOLUTION.