BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDOVATIONS

    MDR report key: 8502004 · Received April 10, 2019

    Report

    Report Number
    2183446-2018-00002
    Event Type
    Injury
    Date Received
    April 10, 2019
    Date of Event
    October 17, 2018
    Report Date
    January 1, 2019
    Manufacturer
    DIVERSATEK HEALTHCARE
    Product Code
    KNQ
    UDI-DI
    00816734020975
    PMA / PMN Number
    K924646
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED AN ESOPHAGEAL PERFORATION AND REPAIR THROUGH THORACIC SURGERY. THE DEVICE WAS NOT RETURNED FOR EVALUATION BY THE MANUFACTURER. HOWEVER, THE DEVICE HISTORY RECORD OF THE MANUFACTURING LOT WAS REVIEWED AND NO ISSUES WERE RECORDED. THE MANUFACTURER ALSO REVIEWED COMPLAINT TRENDING REPORTS. NO SIMILAR ISSUES HAVE BEEN REPORTED IN ANY COMPLAINT TRENDS. THEREFORE, THE MANUFACTURER BELIEVES THIS TO BE AN ISOLATED INCIDENT RELATED TO USE OF THE DEVICE. THIS IS A REUSABLE DEVICE THAT WAS APPROXIMATELY 4-1/2 YEARS OLD. THE INSTRUCTIONS FOR USE STATE "VISUALLY INSPECT THE GUIDEWIRE FOR SIGNS OF WEAR OR DEGRADATION SUCH AS KINKS, BENDS, OR BREAK. WORN GUIDEWIRES SHOULD NOT BE USED AS THEY MAY NOT PERFORM AS EXPECTED". KINKED OR WORN DEVICES WILL KINK MORE EASILY DURING USE. ADDITIONALLY, PERFORATIONS ARE A KNOWN CONTRAINDICATION FOR ESOPHAGEAL PROCEDURES. THE INSTRUCTIONS FOR USE STATE: "CONTRAINDICATIONS INCLUDE THOSE SPECIFIC TO UPPER GI ENDOSCOPY. CONTRAINDICATIONS TO DILATION INCLUDE, BUT ARE NOT LIMITED TO: UNCOOPERATIVE PATIENT; ASYMPTOMATIC STRICTURES; INABILITY TO ADVANCE THE DILATOR THROUGH THE STRICTURED AREA; COAGULOPATHY; KNOWN OR SUSPECTED PERFORATION; SEVERE INFLAMMATION OR SCARRING NEAR THE DILATION SITE, RECENT MYOCARDIAL INFARCTION, ACTIVE ULCER AND SEVERE CERVICAL ARTHRITIS". THE DEVICE DESIGN AND MANUFACTURING IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT. (B)(4) HAS DETERMINED THAT THERE ARE NO NEW SAFETY OR EFFICACY ISSUES AS A RESULT OF THIS EVENT AND THEREFORE, NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    DURING AN ESOPHAGOGASTRODUODENOSCOPY SAVORY DILATROES WITH GUIDE-WIRE WAS USED. GUIDE-WIRE COULD NOT BE REMOVED. IMAGING STUDIES REVEALED GUIDE WIRE KINKED OUTSIDE OF ESOPHAGUS WITH SMALL PNEUMOTHORAX. PATIENT TRANSFERRED TO A HIGHER LEVEL OF CARE FACILITY. CARDIOTHORACIC SURGERY PERFORMED TO EXTRACT THE WIRE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292330 MEDOVATIONS SAFEGUIDE GUIDE WIRE WITH SPRING TIP KNQ DIVERSATEK HEALTHCARE 1214-02 214616 00816734020975

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R