BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADELANTE PEEL-AWAY INTRODUCER SET

    MDR report key: 16414435 · Received February 21, 2023

    Report

    Report Number
    1035166-2023-00015
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Date of Event
    December 22, 2022
    Report Date
    August 7, 2023
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    10885672100046
    PMA / PMN Number
    K073100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP 1. THE DEVICE USED IN TREATMENT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THEREFORE, THE EXACT CAUSE OF THE PRODUCT ISSUE CANNOT BE DETERMINED AND THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. HOWEVER, THE FOLLOWING CONTROLS ARE IN PLACE TO MITIGATE THE REPORTED PRODUCT ISSUE. 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

    CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE. 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

    THE CLINICIAN REPORTS MORE FRICTION THAN USUAL AS THE LEAD (PLEXA S 65) SLIDES INTO THE INTRODUCER DURING AN IMPLANTATION PROCEDURE. MOREOVER, AT THE TIME OF CUTTING, EVEN IF A LOT OF FORCE IS APPLIED TO THE FINS, THE INTRODUCER IS NOT CUT. IT HAD TO BE CUT WITH SCISSORS TO GET IT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677674 ADELANTE PEEL-AWAY INTRODUCER SET INTRODUCER, CATHETER DYB OSCOR INC. AP08016B5 DP-17196 10885672100046

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown