BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO-INTRODUCER

    MDR report key: 7674831 · Received July 10, 2018

    Report

    Report Number
    2134812-2018-00045
    Event Type
    Injury
    Date Received
    July 10, 2018
    Date of Event
    June 7, 2018
    Report Date
    June 12, 2018
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    DYB
    PMA / PMN Number
    K180913
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SHEATH WAS RETURNED TO VSI FOR EVALUATION. THE HUB OF THE SHEATH WAS SEPARATED FROM THE SHAFT. A MANUFACTURING RECORD REVIEW WAS COMPLETED AND ZERO NONCONFORMANCES WERE FOUND. THE RETURNED PRODUCT EVALUATION CONFIRMED THE FAILURE. AN INTERNAL CORRECTIVE ACTION WAS INITIATED.

    Description of Event or Problem · 1

    TECH SCRUBBED IN DURING PROCEDURE EXPLAINED WHAT HE OBSERVED. MICRO-INTRODUCER SHEATH SEPARATED FROM HUB. PHYSICIAN OBTAINED JUGULAR VEIN ACCESS US GUIDED, UPON REMOVING MICRO SHEATH, THE HUB CAME APART FROM DISTAL SHEATH PORTION. THE ACCOUNT CLAIMS NOTHING OUT OF ORDINARY DURING ACCESS. THEY HAD TO SNARE THE DISTAL SHEATH PORTION FROM JUGULAR VEIN. ADDITIONAL INFORMATION RECEIVED (B)(6) 2018. PHYSICIAN STATED. 'HE OBTAINED JUGULAR ACCESS WITH US. HE REMOVED THE DILATOR AND WIRE. HE TRIED INSERTING A BENSON WIRE FLOPPY END AND WOULD NOT TRAVERSE/INSERT INTO MICRO SHEATH. HE SAID THE HUB FELL OFF THE SHEATH AND FELL BESIDE THE PATIENT ON STERILE FIELD. PHYSICIAN OBTAINED ACCESS A COUPLE CENTIMETERS ABOVE ORIGINAL STICK AND SNARED DISTAL SHEATH WITH GOOSE NECK SNARE WITH NO RESISTANCE. CURRENT PATIENT CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516421 MICRO-INTRODUCER INTRODUCER CATHETER DYB VASCULAR SOLUTIONS, INC. 7219V 624295

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention