BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    MDR report key: 1933076 · Received December 20, 2010

    Report

    Report Number
    1820334-2010-00648
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 18, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION. QUALITY CONTROL INSPECTION CONFIRMS THE TYPE AND OUTSIDE DIAMETER OF TUBING FOR THE INNER AND OUTER CATHETERS, AND THAT THE SURFACE OF THE CATHETER IS SMOOTH AND CLEAN, FREE OF EXCESSIVE DENTS AND KINKS PRIOR TO FURTHER PROCESSING. NO PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION. WITHOUT THE COMPLAINT DEVICE, WE ARE UNABLE TO DETERMINE WHAT HAS LED TO THIS FAILURE. HOWEVER, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED RESISTANCE BEYOND ITS DESIGN DUE TO SCARRING AT THE INSERTION SITE. WE ARE CONTINUING TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL. QUALITY ENGINEERING RISK ANALYSIS (QERA) WAS NOT UPDATED IN RESPONSE TO THIS COMPLAINT. THE ADDITION OF THIS COMPLAINT WOUND NOT CHANGE THE OCCURRENCE RATE OR RISK PRIORITY NUMBER. THEREFORE, THE CONCLUSION IS THAT NO FURTHER MITIGATING ACTION IS NECESSARY, IS STILL VALID.

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING A HEART CATHETERIZATION PROCEDURE. DURING THE RADIAL VASCULAR APPROACH, THE INTRODUCER SET BROKE LEAVING A VASCULAR DILATOR IN THE RADIAL ARTERY. VASCULAR SURGERY HAD TO BE CONSULTED. THE PT WAS TAKEN TO THE OPERATING ROOM. INCISION WAS MADE IN THE ARTERY, ARTERY WAS DISSECTED, THE SHEATH WAS GRASPED AND REMOVED INTACT. THE ARTERY WAS THEN REPAIRED. THE PT WAS TAKEN TO THE INTENSIVE CARE UNIT. PT HAS UNDERGONE FREQUENT DOPPLER FLOW ASSESSMENT OF THE ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPUNCTURE TRANSITIONLESS ACCESS SET DRE DILATOR, VESSEL, OR PERCUTANEOUS CATHETERIZATION DRE COOK, INC. NA 2555213

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention