BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDESTAR¿ STEERABLE GUIDING SHEATH

    MDR report key: 16489689 · Received March 6, 2023

    Report

    Report Number
    1035166-2023-00023
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Date of Event
    February 6, 2023
    Report Date
    August 9, 2023
    Manufacturer
    OSCOR.INC
    Product Code
    DYB
    UDI-DI
    00885672010911
    PMA / PMN Number
    K140406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP 1. 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. A REVIEW OF THE MANUFACTURING PROCESSES INDICATES THE PRODUCTION OPERATORS ARE INSTRUCTED TO 100% VISUALLY INSPECT FOR ANY OBVIOUS DEFECT PRIOR TO SHIPMENT. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. 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.

    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 PHYSICIAN COMPLAINED THAT THE LENGTH OF THE GUIDESTAR DILATOR IS 3 CM SMALLER THAN THE ONE FOR VIZIGO. HE REPORTED THAT IT IS SUPER DANGEROUS IF ONE DOES TRANSEPTAL PUNCTURE WITH GUIDESTAR SHEATH. ON THE SALES REP SIDE, IT IS WRITTEN IN NONE OF OUR TRAINING! ONLY BY COMPARING SIDE BY SIDE THE SHEATHS BOXES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864124 GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR.INC D141103 DP-16400 00885672010911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown