BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARRIVE BRAIDED TRANSSEPTAL SHEATH

    MDR report key: 9452445 · Received December 11, 2019

    Report

    Report Number
    1035166-2019-00121
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Date of Event
    November 20, 2019
    Report Date
    May 15, 2020
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00643169530584
    PMA / PMN Number
    K101497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP. B3,B4,D10,G4,G7,H2,H3,H4,H6,H10. CORRECTED DATA: B3,H4. THE DEVICE USED IN TREATMENT. ONE 10F BREEZEWAY INTRODUCER SHEATH WITH DILATOR WAS RETURNED FROM THE CUSTOMER. THERE WERE NO OTHER ACCESSORIES. NO VISIBLE BLOOD WAS FOUND ON OR INSIDE THE SHEATH OR DILATOR. THE HEMOSTATIC VALVE WAS DETACHED FROM THE HUB OF THE SHEATH AND WAS RETURNED FOR EVALUATION. UPON EVALUATION UNDER A 10X MICROSCOPE, THE HEMOSTATIC VALVE LOOKED NORMAL AND THE HELICAL CUTS LOOKED COMPLETELY INTACT AND UNDISTURBED. THE HUB OF THE SHEATH LOOKED NORMAL AND THE RED CAP WAS ATTACHED PROPERLY. IT IS INCONCLUSIVE AS TO HOW THE HEMOSTATIC VALVE BECAME DETACHED FROM THE HUB. THE DEVICE HISTORY RECORD WAS REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. PER QA PROCEDURE ADELANTE BREEZEWAY DILATOR IN-PROCESS AND FINAL INSPECTION) VISUAL INSPECTION: WITH THE NAKED EYE, VERIFY THE SHAPE AND FORM OF HUB AREA. VERIFY THAT THE HUB IS FREE OF DAMAGES AT THE SEAL, BONDED SEAL CAP, HUB, STOPCOCK AND SIDEPORT TUBING. LEAK TESTING IS PERFORMED ON 100% OF THE SHEATHS BY QA PER PROCEDURE PER IFU : ANY DEVICE/COMPONENT INSERTED THROUGH THE HEMOSTATIC VALVE OF THE SHEATH SHOULD BE WETTED AND PLACED THROUGH THE CENTER OF THE VALVE TO PREVENT TEARING OF THE SEAL AND LEAKAGE. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED AS FINDINGS DID NOT IDENTIFY A DESIGN, LABELING OR MANUFACTURING NON-CONFORMITY. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE AND RISK. 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 · 0

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

    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 AT THE BEGINNING OF THE RADIOFREQUENCY PROCEDURE THE PHYSICIAN WASHED THE ARRIVE AND THE HEMOSTATIC VALVE HAS BEEN DETACHED FROM THE DEVICE, SO THE PHYSICIAN REPLACED IT WITH A NEW ONE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244312 ARRIVE BRAIDED TRANSSEPTAL SHEATH INTRODUCER, CATHETER DYB OSCOR INC. 990061-055 C1-13923 00643169530584

    Patients

    Seq Age Sex Outcome Treatment
    1