BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX SV PTA CATHETER

    MDR report key: 1854420 · Received September 30, 2010

    Report

    Report Number
    9710478-2010-00123
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 6, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    LIT
    PMA / PMN Number
    K081417
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE OF A MILDLY CALCIFIED CORONARY LESION, THE FOX SV BALLOON RUPTURED AT 10 ATMOSPHERE (ATM) DURING INFLATION. THERE WAS NO REPORTED PT EFFECT. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOX SV PTA CATHETER LIT ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 651280

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK