BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADELANTE PEEL-AWAY INTRODUCER SET

    MDR report key: 20021395 · Received August 21, 2024

    Report

    Report Number
    1035166-2024-00089
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    July 22, 2024
    Report Date
    August 20, 2024
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    10885672100060
    PMA / PMN Number
    K073100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED TO OSCOR INC. FOR EVALUATION; HOWEVER, A COMPLAINT NOTIFICATION WAS PROVIDED. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVALUATION, OSCOR INC. IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. THE CUSTOMER REPORTED THE PHYSICIAN WAS DISPLEASED WITH HOW MUCH BLEED BACK HE WAS GETTING FROM THE HEMOSTATIC VALVE. THE PRODUCT WAS DISCARDED. THE COMPLAINT IS NON-VERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. 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.

    Description of Event or Problem · 0

    DURING AN IMPLANTATION PROCEDURE THE PHYSICIAN WAS DISPLEASED WITH HOW MUCH BLEED BACK HE WAS GETTING FROM THE HEMOSTATIC VALVE ON THE 9F OSCOR ADELANTE PEEL-AWAY INTRODUCER KIT, HE DESCRIBED THEM AS "HORRENDOUS" AND EXPRESSED HIS DISPLEASURE FOR HOW MUCH BLEEDING THEY ALLOW. THE PROCEDURE WAS SUCCESSFUL, AND THE PRODUCT REMAINS IMPLANTED. THE PEEL-AWAY INTRODUCER KIT WAS USED FOR THE CASE, SPLIT AND DISCARDED AS PER THE STANDARD USE OF THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2359044 ADELANTE PEEL-AWAY INTRODUCER SET INTRODUCER, CATHETER DYB OSCOR INC. AP09016B5 DP-20113 10885672100060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown