BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORMULA 418 RENAL BALLOON-EXPANDABLE STENT

    MDR report key: 9850875 · Received March 18, 2020

    Report

    Report Number
    1820334-2020-00646
    Event Type
    Malfunction
    Date Received
    March 18, 2020
    Date of Event
    March 3, 2020
    Report Date
    March 26, 2020
    Manufacturer
    COOK INC
    Product Code
    NIN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED 19MAR2020. THE STENT DID NOT SLIP OFF THE DELIVERY SYSTEM AS ORIGINALLY REPORTED, BUT RATHER WAS DISCARDED DUE TO THE USER DECIDING TO USE A DIFFERENT SIZE OF PRODUCT. THERE IS NO ALLEGED MALFUNCTION OF THIS DEVICE. FURTHERMORE, NO SERIOUS INJURY OR DEATH WAS ALLEGED TO HAVE TAKEN PLACE. AS SUCH, THE 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. 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 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 1

    COMMON NAME & PRODUCT CODE; NIN, STENT, RENAL. OCCUPATION: SUPPLY CHAIN ASSOCIATE. PMA/510(K) NUMBER; P100028. 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

    IT WAS REPORTED, DURING A PEDIATRIC SUPERIOR VENA CAVA STENTING PROCEDURE, THE STENT FROM THE FORMULA 418 RENAL BALLOON-EXPANDABLE STENT CAME OFF THE BALLOON. ACCORDING TO THE INITIAL REPORTER, WHILE INSERTING THE DEVICE INTO THE ACCESS SHEATH, THE MOUNTED STENT CAME OFF THE DELIVERY SYSTEM. THE PROCEDURE WAS ABLE TO BE COMPLETED USING ANOTHER DEVICE. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314602 FORMULA 418 RENAL BALLOON-EXPANDABLE STENT NIN COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1