BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFEGUIDE GUIDEWIRE WITH SPRING TIP

    MDR report key: 20333114 · Received September 30, 2024

    Report

    Report Number
    2183446-2024-00005
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    August 12, 2024
    Report Date
    September 27, 2024
    Manufacturer
    DIVERSATEK HEALTHCARE
    Product Code
    KNQ
    UDI-DI
    00816734021507
    PMA / PMN Number
    K924646
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED EVENT TO MANUFACTURER ON SEPTEMBER 04, 2024. A SALES REP FROM DIVERSATEK HEALTHCARE WAS ON SITE WITH THE CUSTOMER WHEN THEY TOLD THE SALES REP THERE WAS AN ESOPHAGEAL PERFORATION INCIDENT INVOLVING A DIVERSATEK GUIDEWIRE. AT THAT TIME THEY PROVIDED PICTURES OF THE GUIDEWIRE, BUT DID NOT HAVE THE PHYSICAL DEVICE FOR EVALUATION AS IT HAD BEEN THROWN AWAY. CUSTOMER REPORTED THAT THE SPRING TIP OF THE GUIDEWIRE BENT IN SUCH A WAY AFTER DILATION THAT IT LED TO THE PERFORATION OF THE PATIENT'S ESOPHAGUS. THE BEND TO THE SPRING TIP FORMED A V-SHAPE. THE ACUTE BEND OF THE WIRE DUG INTO THE PATIENTS ESOPHAGUS UPON REMOVAL OF THE WIRE. THE ESOPHAGUS WAS PERFORATED AS A RESULT OF REMOVAL WITH THE EXTREME BEND TO THE TIP. SURGICAL INTERVENTION WAS NEEDED TO REPAIR THE PERFORATION. THE PATIENT WAS HOSPITALIZED FOR AN UNDISCLOSED AMOUNT OF TIME. ADDITIONAL INFORMATION FROM THE CUSTOMER WAS REQUESTED ON 9/04/2024. INFORMATION WAS RECEIVED ON 9/19/2024. THE PATIENT WAS SENT TO ANOTHER FACILITY FOR ADDITINAL TREATMENT AFTER INITIAL MEDICAL INTERVENTION. ADDITIONAL TREATMENT METHODS AND LENGTH OF HOSPITAL STAY WERE NOT DISCLOSED TO THE CUSTOMER FACILTIY OR DIVERSATEK HEALTHCARE. THIS GUIDEWIRE IS USED IN CONJUNCTION WITH A PVC ESOPHAGEAL DILATOR WITH AN INNER LUMEN. THE GUIDEWIRE IS PLACED WITHIN THE PATIENT. THE ESOPHAGEAL DILATOR IS INTRODUCED INTO THE PATIENT OVER THE GUIDEWIRE, WHICH PASSES THROUGH THE INNER LUMEN OF THAT DILATOR. DIVERSATEK HEALTHCARE PERFORMED AN INVESTIGATION BY REVIEWING THE PICTURES PROVIDED BY THE USER FACILITY, PRODUCTION RECORDS OF THIS LOT, THE MANUFACTURING PROCESS, AND THE DEVICE DESIGN. THIS IS A SINGLE-USE DISPOSABLE DEVICE THAT WAS MANUFACTURED ON 2024-03-12. THE DEVICE HISTORY RECORD OF THE PRODUCTION LOT WAS REVIEWED AND NO ISSUES WERE RECORDED. THE MANUFACTURING PROCESS WAS INVESTIGATED AND NO ISSUES WERE NOTED. THE CURRENT DESIGN OF THIS DEVICE HAS BEEN ON THE MARKET SINCE 1998. BASED ON A REVIEW OF THE TRENDING REPORTS AND THE INFORMATION AVAILABLE, THE CAUSE OF THIS MALFUNCTION IS NOT BELIEVED TO BE ANY SYSTEMIC ISSUE RELATED TO DESIGN OR MANUFACTURING. THERE ARE TWO OTHER ADVERSE EVENTS ASSOCIATED WITH THE ESOPHAGEAL DILATOR GUIDEWIRES. THERE WAS A PREVIOUS EVENT IN 2018 FOR THE REUSABLE VERSION OF THIS DEVICE AND ATTRIBUTED TO EXCESSIVE AGE OF THE DEVICE. 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. THE SECOND EVENT NOTED WAS FROM 2021 FOR THE SAME SINGLE-USE DEVICE NOTED IN THIS ADVERSE EVENT. THE GUIDEWIRE WAS PUT IN A TORTUROUS POSITION AND BENT IN THE MIDDLE OF THE WIRE CAUSING AN EXTREME ANGLE THAT LED TO PERFORATION OF THE ESOPHAGUS WHEN REMOVED. 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". BASED ON THE MANUFACTURER'S EVALUATION, THE DEVICE DESIGN AND MANUFACTURING IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT. DIVERSATEK 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 · 0

    CUSTOMER REPORTED EVENT TO MANUFACTURER ON SEPTEMBER 04, 2024. CUSTOMER REPORTED THAT THE SPRING TIP OF THE GUIDEWIRE BENT IN SUCH A WAY AFTER DILATION THAT IT LED TO THE PERFORATION OF THE PATIENT'S ESOPHAGUS. THE BEND TO THE SPRING TIP FORMED A V-SHAPE. THE ACUTE BEND OF THE WIRE DUG INTO THE PATIENTS ESOPHAGUS UPON REMOVAL OF THE WIRE. THE ESOPHAGUS WAS PERFORATED AS A RESULT OF REMOVAL WITH THE EXTREME BEND TO THE TIP. SURGICAL INTERVENTION WAS NEEDED TO REPAIR THE PERFORATION. THE PATIENT WAS HOSPITALIZED FOR AN UNDISCLOSED AMOUNT OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040415 SAFEGUIDE GUIDEWIRE WITH SPRING TIP GUIDEWIRE KNQ DIVERSATEK HEALTHCARE 1214-02D 239603 00816734021507

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H