BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADELANTE® PEEL-AWAY INTRODUCER SET

    MDR report key: 16248954 · Received January 26, 2023

    Report

    Report Number
    1035166-2023-00011
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    January 5, 2023
    Report Date
    November 1, 2023
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    10885672100022
    PMA / PMN Number
    K073100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER DID NOT PROVIDE THE EVENT DATE, HOWEVER, ON (B)(6) 2023, THEY SUBMITTED THEIR EVENT REPORT FORM. BASED UPON THIS INFORMATION, THIS IS THE DATE WE ARE SUBMITTING AS THE EVENT DATE. SHOULD THE ACTUAL EVENT DATE BE PROVIDED, WE WILL UPDATE OUR REPORT ACCORDINGLY. CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP 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.

    Additional Manufacturer Narrative · 0

    ONE 7F ADELANTE INTRODUCER SHEATH WAS RETURNED FROM THE CUSTOMER WITH THE DILATOR, SYRINGE AND GUIDEWIRE. THERE WERE NO OTHER ACCESSORIES. NO VISIBLE BLOOD WAS FOUND ON OR INSIDE THE SHEATH OR DILATOR. ACCORDING TO THE EVENT DESCRIPTION SUMMARY, DURING IMPLANTATION, BEFORE INSERTING THE SHEATH, IT WAS NOTICED THAT THE TIP OF THE INTRODUCER IS FRAYED. THE MATERIAL WAS NOT USED, IT WAS UNPACKED AND PREPARED ON THE STERILE TABLE. AFTER REVIEW OF THE RETURNED PRODUCT UNDER A MICROSCOPE, IT WAS FOUND THAT THE TIP OF THE SHEATH LOOKED NORMAL AND ROUND, BUT THE TIP OF THE DILATOR LOOKED LIKE IT HAD SUSTAINED IMPACT DAMAGE. RETURNED DEVICE ANALYSIS REVEALED THE SHEATH AND DILATOR WERE WITHIN MANUFACTURING SPECIFICATIONS. THE TIP OF THE SHEATH LOOKED NORMAL AND THE TIP OF THE DILATOR LOOKED LIKE IT HAD SUSTAINED IMPACT DAMAGE. POTENTIAL CONTRIBUTING FACTORS TO THE DAMAGE COULD HAVE BEEN IF THE DEVICE WAS DROPPED, BUMPED OR MISHANDLED. THE DILATOR TIPS ARE INSPECTED FOR DAMAGE BY QA 100% DURING THE PACKAGING PROCEDURE, JUST PRIOR TO SHIPPING TO THE CUSTOMER. NO MANUFACTURING DEFECTS WERE FOUND. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. PER PROCEDURE (ADELANTE INTRODUCER SET IN-PROCESS AND FINAL INSPECTION): SAMPLING PLAN ANSI Z 1.4, GENERAL LEVEL I, NORMAL, AQL 0.25 WITH THE NAKED EYE, VERIFY THE DILATOR/SHEATH ARE FREE OF KINKS, CRACKS, SPLITS, SINKS, EXCESSIVE FLASH, LOOSE/EMBEDDED FM, DAMAGED TIPS OR ANY OTHER DEFECTS OR DAMAGES ON ENTIRE ASSEMBLY. PER PROCEDURE (INTRODUCER KIT PACKAGING INSPECTION): SAMPLE SIZE 100% ENSURE DILATOR TIP IS PERFECTLY ROUND AND WELL OPENED. THE INSTRUCTIONS FOR USE (IFU) INFORMS THE USER: DO NOT ADVANCE THE GUIDEWIRE OR INTRODUCER ASSEMBLY UNDER RESISTANCE. DETERMINE THE CAUSE OF RESISTANCE THROUGH FLUOROSCOPIC EXAMINATION. ADVANCE THE SHEATH AND DILATOR SIMULTANEOUSLY TO PREVENT DAMAGE TO THE SHEATH TIP. NO FURTHER FOLLOW-UP IS REQUIRED. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED AS FINDINGS DID NOT IDENTIFY A DESIGN, LABELING OR MANUFACTURING NON-CONFORMITY. IN ADDITION, THERE WAS NO NEW FAILURE MODE IDENTIFIED AND THE RISK REMAINS ACCEPTABLE. 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.

    Description of Event or Problem · 0

    DURING IMPLANTATION, BEFORE INSERTING THE SHEATH, IT IS NOTICED THAT THE TIP OF THE INTRODUCER IS FRAYED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. CUSTOMER DID NOT PROVIDE THE EVENT DATE, HOWEVER, ON (B)(6)2023, THEY SUBMITTED THEIR EVENT REPORT FORM. BASED UPON THIS INFORMATION, THIS IS THE DATE WE ARE SUBMITTING AS THE EVENT DATE. SHOULD THE ACTUAL EVENT DATE BE PROVIDED, WE WILL UPDATE OUR REPORT ACCORDINGLY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE EVENT DATE IS 05/JAN/2023. ADDITIONALLY, THERE WAS NO PROCEDURE DELAY, NO MEDICAL INTERVENTION OR ADDITIONAL SURGERY REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER PRODUCT. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785414 ADELANTE® PEEL-AWAY INTRODUCER SET INTRODUCER, CATHETER DYB OSCOR INC. AP07016B5 DP-16383 10885672100022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown