BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    MDR report key: 8141338 · Received December 7, 2018

    Report

    Report Number
    2522007-2018-00028
    Event Type
    Injury
    Date Received
    December 7, 2018
    Date of Event
    August 24, 2018
    Report Date
    November 28, 2018
    Manufacturer
    COOK VASCULAR INC.
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT CORRECTS AN ERROR REGARDING MANUFACTURER REPORT # 3001845648-2018-00471 SUBMITTED ON OCTOBER 4, 2018. THE DEVICE IDENTIFIED IN THE INITIAL REPORT IS INCORRECT (CATALOG # EVO-FC-10-11-8-B). THE CORRECT DEVICE TO WHICH THIS ADVERSE EVENT CAN "BEE" ATTRIBUTED "TO" IS LR-EVN-11.0. THE INTENTION OF THIS REPORT IS TO IDENTIFY THE CORRECT DEVICE AS WELL AS THE CORRECT DEVICE MANUFACTURER ((B)(4)). PMA/510(K)#: 142301. THIS IS THE INITIAL REPORT UNDER COOK (B)(4) INC. WITH THE COMPLAINT FOR LR-EVN-11.0. A FOLLOW UP REPORT WILL BE "SUMMITED" UPON RECEIPT OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    A LEAD MANAGEMENT CASE WAS REPORTED TO SPECTRANETICS IN WHICH AN ADVERSE EVENT OCCURRED AND A COOK EVOLUTION WAS REPORTEDLY IN USE. DATE OF PROCEDURE: ON (B)(6) 2018. EVENT WAS INITIALLY REPORTED THAT A SPECTRANETICS TIGHTRAIL DEVICE BLADE MECHANISM DID NOT ACTIVATE. HOWEVER, ADDITIONAL INFORMATION WAS OBTAINED FROM (B)(4), QUALITY ASSURANCE ASSISTANT, PHILIPS, WHO SPOKE WITH THE SALES REPRESENTATIVE. THERE WAS NO REPORTED HARM TO THE PATIENT DUE TO THE TIGHTRAIL DEVICE; HOWEVER, THE PHYSICIAN DECIDED TO USE A COOK MEDICAL DEVICE (EVOLUTION) AND AN ADVERSE EVENT OCCURRED. ADDITIONAL INTERVENTION WAS NEEDED, WHICH RESULTED IN AN OPEN THORAX, BUT CASE WAS SUCCESSFULLY COMPLETED AND PATIENT IS REPORTEDLY RECOVERING FROM THE SURGERY AT HOME. SPECTRANETICS HAS NO FURTHER INFORMATION ON THE COOK DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983863 LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention