BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISIONS 8.2

    MDR report key: 1306490 · Received February 5, 2009

    Report

    Report Number
    2939520-2009-00003
    Event Type
    Other
    Date Received
    February 5, 2009
    Date of Event
    December 22, 2008
    Report Date
    February 4, 2009
    Manufacturer
    VOLCANO CORP.
    Product Code
    IYO
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS REQUESTED FROM THE USER FOR INVESTIGATION, HOWEVER IT WAS NOT RETURNED. SINCE THE DEVICE WAS NOT RETURNED, A COMPLETE INVESTIGATION INCLUDING EXAMINATION AND TESTING OF THE DEVICE WAS NOT POSSIBLE. ALSO, REQUESTS FOR ADDITIONAL INFORMATION OR PICTURES WHICH WOULD HAVE FURTHERED THE INVESTIGATION WERE NOT PROVIDED. THEREFORE THE COMPLAINT COULD NOT BE VERIFIED. IF ADDITIONAL INFORMATION BECOMES KNOWN, A SUPPLEMENTAL REPORT WILL BE FILED. HOWEVER, BY LOOKING AT MANUFACTURING DOCUMENTS AND OTHER VISIONS 8.2 CATHETERS FROM DIFFERENT LOTS, WE HAVE DETERMINED THAT IT IS UNLIKELY A 3MM PORTION OF THE CATHETER TIP OR LUBRICIOUS COATING COULD BE "SHEARED OFF" AS DESCRIBED. THE LUBRICIOUS COATING MATERIAL IS SLYDEX WHICH GIVEN ITS PROPERTIES DOES NOT DRY TO A STATE WHICH WOULD SHEAR OR DETACH. ADDITIONALLY, BIOCOMPATIBILITY TESTING HAS BEEN PERFORMED ON THE DEVICE, WHICH INCLUDED THE COATING. (B)(4) - THE USER FACILITY REPORTED THE PATIENT WAS DISCHARGED WITH NO APPARENT SEQUELAE.

    Description of Event or Problem · 1

    PATIENT WITH BILATERAL FEMORAL VEIN STENTS ADMITTED WITH RIGHT LOWER EXTREMITY EDEMA AND PAIN. VASCULAR SURGEON PERFORMED A FEMORAL VEIN PUNCTURE UNDER ULTRASOUND GUIDANCE, SELECT CANNULATION OF INFERIOR VENA CAVA, C-ARM WITH MULTIPLE ILIAC AND IVC VENOGRAM, IVUS EXAMINATION OF IVC, CIV, EIV, AND CFV, BALLOON DILATATION OF IVC AND CIV. AT THE END OF THE PROCEDURE, UPON REMOVAL OF THE IVUS, IT WAS NOTED THAT THE COATING OF THE VERY TIP OF THE IVUS CATHETER, "ABOUT 3MM" IN LENGTH WAS NO LONGER PRESENT. "THE CATHETER ITSELF WAS INTACT JUST A COATING APPEARED TO HAVE BEEN SHEARED OFF." DIGITAL FLUOROSCOPY OF BOTH LUNGS AND ABDOMEN REVEALED NO FOREIGN BODY. CT OF THORAX, ABDOMEN AND PELVIS OBTAINED AND NO FOREIGN BODY WAS NOTED. SURGEON NOTIFIED PATIENT AND FAMILY OF EVENTS. PATIENT WAS DISCHARGED HOME LATER THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIONS 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHET IYO VOLCANO CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other