BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPHERE INFLATION DEVICE

    MDR report key: 10522499 · Received September 11, 2020

    Report

    Report Number
    1820334-2020-01666
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    September 9, 2020
    Report Date
    May 3, 2021
    Manufacturer
    COOK INC
    Product Code
    MAV
    UDI-DI
    10827002310275
    PMA / PMN Number
    K953522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS A CORRECTION. UPON FURTHER REVIEW, IT HAS BEEN DETERMINED THAT ATRION IS THE LABELED MANUFACTURER OF THE COMPLAINT DEVICE AND IS THEREFORE RESPONSIBLE FOR ALL REGULATORY REPORTING AND COMPLAINT INVESTIGATION REQUIREMENTS. THE COMPLAINT INFORMATION HAS BEEN PROVIDED TO THE MANUFACTURER (ATRION) AND ENTERED IN THE COMPLAINT FILE BY COOK INC.

    Additional Manufacturer Narrative · 0

    DESCRIPTION OF EVENT: INVESTIGATION ¿ EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. THE COMPLAINT DEVICE WAS RETURNED TO CINC. THERE WAS NO DAMAGE NOTED TO THE DEVICE IN THE INITIAL CHECK IN AT CINC. THE DEVICE WAS THEN SHIPPED TO THE SUPPLIER ATRION FOR THE DEVICE FAILURE ANALYSIS TO BE COMPLETED. THE COMPLETE SUPPLIER INVESTIGATION IS ATTACHED TO THE COMPLAINT FILE. THE SUPPLIER COULD NOT CONFIRM THE COMPLAINT AS MANUFACTURING RELATED BECAUSE THE GAUGE WAS DISCOVERED TO EXHIBIT CRYSTALLIZATION AND CORROSION, THE HOSE EXHIBITED DISCOLORATION, AND SCUFFING WAS OBSERVED ON THE THREADS OF THE PLUNGER, WHICH WAS ALL INDICATIVE OF RE-USE OF THE DEVICE. THE CORROSION/CRYSTALLIZATION WAS NORMALLY OBSERVED AFTER A LIQUID, HAD BEEN INTRODUCED TO THE DEVICE AND ALLOWED TO EVAPORATE. THIS CORROSION/CRYSTALLIZATION PREVENTED THE GAUGE FROM BEING RESPONSIVE DURING ORIGINAL FUNCTIONAL TESTING, AND WAS BELIEVED TO HAVE BROKEN LOOSE FROM PRESSURIZATION FINALLY ALLOWING THE GAUGE TO RESPOND. THE SUPPLIER'S MANUFACTURING PROCESS WAS A DRY PROCESS, AND THERE ARE NO FLUIDS INTRODUCED TO THE DEVICE AT ANY POINT AFTER ASSEMBLY. THEREFORE, THERE ARE NO ASSIGNABLE CORRECTIVE ACTIONS TO BE TAKEN AT THIS TIME. THANK YOU FOR YOUR FEEDBACK. THIS REPORT CONCLUDES OUR INVESTIGATION OF THE ABOVE LISTED COMPLAINTS. THE INFORMATION GENERATED OR DATA ACCUMULATED WILL BE FILED FOR FUTURE REFERENCE, TRENDS, OR AUDITS. WE WILL CONTINUE TO MONITOR AND TREND ANY PROBLEMS ASSOCIATED WITH THIS DEVICE AS WE STRIVE TO CONTINUOUSLY IMPROVE OUR PRODUCTS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS ONE OTHER COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT. THE OTHER COMPLAINT WAS FROM THE SAME FACILITY (PR308902), HOWEVER THE INVESTIGATION DETERMINED THAT THIS COMPLAINT WAS NOT DUE TO MANUFACTURING ISSUES. WITH THIS INFORMATION IN MIND THERE IS OBJECTIVE EVIDENCE TO SUPPORT THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. WHILE A DEFINITIVE CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED, THE SUPPLIER INVESTIGATION ON THE LOT CONCLUDED THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. IT WAS DISCOVERED THAT THE GAUGE EXHIBITED CRYSTALLIZATION AND CORROSION INDICATE OF RE-USE OF THE DEVICE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    COMMON NAME & PRODUCT CODE = PTM SYRINGE, BALLOON INFLATION, EXEMPT; KOE DILATOR, URETHRAL. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A SPHERE INFLATION DEVICE MANOMETER DID NOT FUNCTION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989936 SPHERE INFLATION DEVICE MAV COOK INC 96271420 10827002310275

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR