BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADELANTE BREEZEWAY

    MDR report key: 9304103 · Received November 11, 2019

    Report

    Report Number
    1035166-2019-00093
    Event Type
    Malfunction
    Date Received
    November 11, 2019
    Date of Event
    October 10, 2019
    Report Date
    January 10, 2020
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00885672101787
    PMA / PMN Number
    K101497
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP. B4,D10,G4,G7,H2,H3,H6,H10. THE DEVICE USED IN TREATMENT. ONE 8F ADELANTE BREEZEWAY SHEATH RETURNED FROM THE CUSTOMER. DEVICE RECEIVED OUT OF POUCH PACKAGING. DILATOR WAS INSIDE THE SHEATH IN OUTER BOX. NO POUCH NOR TRAY WAS RETURNED. THERE WERE NO OTHER ACCESSORIES. AFTER EVALUATION OF THE RETURNED PRODUCT, IT WAS FOUND THAT THE DILATOR LENGTH IS OUT OF SPECIFICATION. THE LENGTH OF RETURNED PRODUCTS MEASURED AS FOLLOWS: PER DILATOR DRAWING DILATOR LENGTH (AFTER THE TIPPING) SPECIFICATION IS 836 +/- 5MM (831MM - 841MM).WHEN MEASURED WITH A CALIBRATED METRIC RULER, DILATOR MEASURED AT 823MM AND NOT WITHIN MANUFACTURING SPECIFICATION. PER SHEATH DRAWING SHEATH USABLE LENGTH SPECIFICATION IS 788+/-1MM. WHEN MEASURED WITH A CALIBRATED METRIC RULER SHEATH MEASURED AT 788MM. INVESTIGATION CONFIRMED THE GAP BETWEEN DILATOR AND SHEATH. THE PROBABLE CAUSE OF THIS NONCONFORMANCE CANNOT BE DETERMINED BUT COULD BE RELATED TO OVERMOLDING OR TIPPING PROCESS WHERE DILATOR IS CUT TO REQUIRED LENGTH AND MEASURED FOR SPECIFICATION. THE ISSUE IS FOUND TO BE AN ISOLATED INCIDENT AND RELATED TO AN OPERATOR ERROR. AS PER NON-PEELABLE INTRODUCER SET TIPPING PROCEDURE, DILATORS ARE INSPECTED100% FOR LENGTH MEASUREMENTS. AS PER ADELANTE BREEZEWAY DILATOR IN PROCESS AND FINAL INSPECTION FOLLOWING STEPS ARE PERFORMED PRIOR TO RELEASE OF THE PRODUCT. INSPECTION STEPS AFTER OVERMOLDING THE DILATOR: FIRST 5 GOOD SHOTS AND LAST 5 SHOTS, INSPECT 100%. REMAINING SHOTS SAMPLE AT 65% AQL. MEASURE DIMENSIONS: LENGTH FROM END OF HUB TO TIP SHOULD BE IN RANGE OF: ADELANTE BREEZEWAY D84CM: 836-846 MM - INSPECTION STEPS AFTER TIPPING OF THE DILATOR: FIRST 5 PROPERLY TIPPED PARTS, LAST 5 PARTS INSPECT 100%. REMAINING SHOTS SAMPLE AT 65% AQL. MEASURE DIMENSIONS: LENGTH FROM PROXIMAL END OF THE DILATOR TUBE TO THE TIP SHOULD BE IN RANGE OF: ADELANTE BREEZEW D84CM: 831-844 MM. PER IFU GENERAL USE:SELECT APPROPRIATE SIZE OF THE SHEATH FOR THE DEVICE TO BE DELIVERED. PLACE A GUIDEWIRE ACCORDING TO ITS OWN SUPPLIED INSTRUCTIONS FOR USE. PLACE DILATOR INSIDE THE SHEATH AND LOCK BOTH HUBS TOGETHER. THREAD THE DILATOR/SHEATH ASSEMBLY OVER THE GUIDEWIRE, USING A SLIGHT TWISTING MOTION. PERSONAL AWARENESS TRAINING HAS BEEN CONDUCTED TO PREVENT THE REOCCURRENCE OF THIS ISSUE. BASED ON INVESTIGATION CAPA IS NOT REQUIRED. THE EVENT WILL BE REEVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE. OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    OUR INVESTIGATION IS STILL IN PROGRESS ,FOLLOW UP REPORT WILL BE SUBMITTED IF WE FIND ANY FURTHER ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THROMBECTOMY PROCEDURE USER FIND INTERNAL DILATOR WAS SHORT FOR THE SHEATH WHICH CAUSE STEPDOWN FROM THE OPENING IN THE SHEATH TO THE DILATOR. PRODUCT HAD AN OBLONG TIP THAT CREATED A GAP BETWEEN THE SHEATH AND TRANSSEPTAL NEEDLE. DEVICE WAS NOT INSERTED INTO PATIENT. NO ADVERSE EVENT REPORTED AND NO ADDITIONAL INFORMATION IS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101670 ADELANTE BREEZEWAY INTRODUCER, CATHETER DYB OSCOR INC. AB081045 C1-16755 00885672101787

    Patients

    Seq Age Sex Outcome Treatment
    1