BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIONS PV 8.2F IVUS CATHETER

    MDR report key: 1629252 · Received March 10, 2010

    Report

    Report Number
    2939520-2010-00014
    Event Type
    Injury
    Date Received
    March 10, 2010
    Date of Event
    February 25, 2010
    Report Date
    March 1, 2010
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    PMA / PMN Number
    K071660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE DOCUMENTATION FOR THIS LOT WAS REVIEWED AND TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT. MANUFACTURING DOCUMENTATION WAS REVIEWED AND THERE WERE NO DEVIATIONS OR NON-CONFORMANCES THAT WOULD REASONABLY BE EXPECTED TO CONTRIBUTE TO THE REPORTED FAILURE MODE. THE DEVICE WAS VISUALLY EVALUATED AND APPROXIMATELY 2CM OF THE DISTAL TIP WERE MISSING FROM THE DEVICE WITH THE SEPARATION OCCURRING AT THE JOINT BETWEEN THE DISTAL SHAFT AND THE SCANNER. MATERIAL ELONGATION AND FEATHERING WERE PRESENT AT THE LOCATION OF SEPARATION, INDICATING THE DEVICE EXPERIENCED SEVERE FORCE. THE DISTAL TIP WAS NOT RETURNED FOR EVAL SO IT IS NOT POSSIBLE TO DETERMINE IF ALL PARTS ARE ACCOUNTED FOR. THE USER REPORTED THAT THE SEPARATION OCCURRED DURING PULLBACK THROUGH AN 8F INTRODUCER SHEATH AND THAT MORE RESISTANCE THAN NORMAL WAS EXPERIENCED. THE VISIONS 8.2 IFU STATES A MINIMUM INTRODUCER SHEATH OF 9F IS COMPATIBLE WITH THIS DEVICE. ADDITIONALLY, THE IFU STATES, "IF RESISTANCE IS ENCOUNTERED DURING PULLBACK, REMOVE THE ENTIRE SYSTEM (GUIDE WIRE, IVUS CATHETER, SHEATH/GUIDE CATHETER) AT THE SAME TIME." THERE WAS NO INDICATION OF DEVICE DEFECT OR THAT THE DEVICE WAS NOT MANUFACTURED TO DEVICE SPECIFICATIONS DURING EVAL. NO PT ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    DURING TREATMENT FOR A THORACIC ANEURISM, THE DISTAL TIP (PROBE) OF A VISIONS PV 8.2F IVUS CATHETER BECAME SEPARATED FROM THE CATHETER UPON REMOVAL FROM THE INTRODUCER SHEATH (8F). MORE RESISTANCE THAN USUAL WAS EXPERIENCED DURING PULL-BACK. WHEN THE DEVICE WAS REMOVED AND CHECKED, THE PROBE WAS NOT ATTACHED. A SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE PROBE FROM THE PT. AT THE TIME OF THIS REPORT, THE PT IS REPORTED TO BE STABLE AND WAS RELEASED WITHOUT EXTENDED HOSPITALIZATION. NO ADVERSE EVENTS OCCURRED DUE TO THE SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIONS PV 8.2F IVUS CATHETER INTRAVASCULAR ULTRASOUND CATHETER OBJ VOLCANO CORPORATION 88900 00402637

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention