BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DILATOR

    MDR report key: 12207080 · Received July 21, 2021

    Report

    Report Number
    1820334-2021-01845
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    July 12, 2021
    Report Date
    July 21, 2021
    Manufacturer
    COOK INC
    Product Code
    DRE
    UDI-DI
    00827002023666
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. CORRECTION: UPON FURTHER REVIEW, IT WAS DETERMINED THIS EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY OR REPORTABLE PRODUCT MALFUNCTION AS THERE IS NO INDICATION OF THE MALFUNCTION LEADING TO AN AE. FURTHER DISCUSSION WITH REGULATORY REPORTING, CLINICAL SPECIALISTS, AND MEDICAL ADVISOR DETERMINED THAT THE "PHYSICIAN WAS ABLE TO GRASP THE DILATOR AND REMOVE IT OVER THE WIRE THAT WAS IN PLACE, AS THERE WAS A PORTION OF IT EXTRAVASCULAR" DOES NOT CONSTITUTE MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OR DEATH FOR THIS EVENT. THEREFORE, THIS EVENT IS NO LONGER CONSIDERED A SERIOUS INJURY PER 21 CFR PART 803.3. ADDITIONALLY, A REVIEW OF REPORTING SOFTWARE REVEALED THAT NO SIMILAR EVENTS WHERE THE NCD DILATOR SEPARATED RESULTED IN HEIGHTENED PATIENT RISK. AS THERE ARE NO RECORDED INCIDENCES OF SERIOUS INJURY DUE TO THE REPORTED FAILURE MODE AND IT IS NOT LIKELY THAT SERIOUS INJURY WOULD RESULT IF THE EVENT WERE TO RECUR THE EVENT IS NOT REPORTABLE PER 21CFR PART 803.50. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT. SEE H10.

    Additional Manufacturer Narrative · 1

    OCCUPATION: UNKNOWN. PMA/510K: PREAMENDMENT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING A PORT INSERTION PROCEDURE IT WAS REPORTED THAT A COOK DILATOR SEPARATED UPON REMOVAL. NO RESISTANCE WAS ENCOUNTERED UPON THE REMOVAL. THE PHYSICIAN WAS ABLE TO REMOVE THE PORTION OF THE SEPARATED DILATOR THAT WAS "EXTRAVASCULAR" OVER THE WIRE THAT WAS IN PLACE. NO ADDITIONAL PROCEDURES WERE REQUIRED. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101870 DILATOR DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK INC G02366 13827656 00827002023666

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention