BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE

    MDR report key: 7114731 · Received December 13, 2017

    Report

    Report Number
    1820334-2017-04345
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    November 29, 2017
    Report Date
    December 20, 2017
    Manufacturer
    COOK INC
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: (B)(4). ADDITIONAL INFORMATION: ON 18DEC2017 IT WAS PROVIDED THAT DURING AN IVC FILTER INSERTION, A SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE HAD SOME DIFFICULTY BEING INSERTED RATHER THAN THE INITIAL REPORT OF IT BEING "DISLODGED." IT WAS REPORTED THAT ACCESS WAS GAINED VIA THE COMMON FEMORAL VEIN. THE COMPLAINT WIRE WAS THEN TAKEN FROM PACKAGE AND INSERTED INTO SMALL PURPLE INTRODUCER. IT WAS NOTED THAT THE PHYSICIAN MENTIONED HEARING A "CLICK" WHEN INSERTING THE WIRE INTO THIS INTRODUCER. HE PROCEEDED TO TRY TO PUT THE WIRE AND PURPLE INTRODUCER INTO THE INTRODUCER PLACED IN THE ACCESS SITE, BUT IT "WOULDN'T FIT." THE PHYSICIAN THEN DECIDED NOT TO USE THIS DEVICE AND DISCARDED THE ITEMS. ANOTHER WIRE WAS USED TO COMPLETE THE PROCEDURE. IT HAS BEEN CONFIRMED THAT NO PART OF THE WIRE WAS "DISLODGED." NO HARM WAS CAUSED TO THE PATIENT. PRODUCT CODE: DQX. THIS EVENT IS NO LONGER REPORTABLE ACCORDING TO 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY AND/OR PRODUCT MALFUNCTION AS THERE IS NO PRECEDENCE OF THIS MALFUNCTION LEADING TO AN AE.

    Additional Manufacturer Narrative · 1

    COMMON NAME & PRODUCT CODE = UNAVAILABLE AS DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. PMA/510(K) NUMBER = UNAVAILABLE AS DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE ROSEN WIRE GUIDE DISLODGED. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892032 SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQY COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1