BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS QUICK-CROSS SUPPORT CATHETER

    MDR report key: 8395001 · Received March 6, 2019

    Report

    Report Number
    1721279-2019-00032
    Event Type
    Injury
    Date Received
    March 6, 2019
    Date of Event
    December 31, 2018
    Report Date
    June 21, 2024
    Manufacturer
    THE SPECTRANETICS CORPORATION
    Product Code
    DQY
    UDI-DI
    00813132020651
    PMA / PMN Number
    K033678
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURE¿S POLICY. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE INFORMATION LISTED IN THE INITIAL MDR WAS INCORRECT. THE COMMON DEVICE NAME WAS UPDATED TO CATHETER, PERCUTANEOUS (FROM QUICK-CROSS). THE UDI WAS UPDATED TO (B)(4). 510(K) NUMBER UPDATED TO K033678 (FROM K150201). SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION WAS PROVIDED ON THE FACILITY MEDWATCH MW5083367. INITIAL REPORTER INFORMATION WAS NOT INCLUDED ON THE FACILITY MEDWATCH MW5083367. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2019 A PHILIPS POST MARKET SURVEILLANCE EMPLOYEE RECEIVED THE FOLLOWING USER FACILITY MEDWATCH FROM THE FDA, MEDWATCH MW5083367. DISTAL TIP OF CATHETER BROKE OFF DURING ATTEMPT TO ADVANCE IT. TIP RETRIEVED WITH OUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187438 SPECTRANETICS QUICK-CROSS SUPPORT CATHETER CATHETER, PERCUTANEOUS DQY THE SPECTRANETICS CORPORATION 518-034 FQU18G03A 00813132020651

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention