BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 1890304 · Received October 22, 2010

    Report

    Report Number
    9710478-2010-00133
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    LIT
    PMA / PMN Number
    K081417
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED FOX PLUS CATHETER FOUND THAT THERE WERE NO KINKS OR ANY OTHER DAMAGE. THE BALLOON WAS RECEIVED UNFOLDED. THE SOFT TIP WAS OBSERVED AND IT WAS CONSIDERED TO BE CONFORMING. ALSO THE DISTAL AND PROXIMAL BALLOON END AND MARKER DID NOT SHOW ANY ABNORMALITIES. THE INFLATION OF THE BALLOON COULD NOT BE PERFORMED BECAUSE OF THE MATERIAL RUPTURE. THE DEVICE SHOWED A PINHOLE AT THE DISTAL PART OF BALLOON. AS STATED IN THE CASE DESCRIPTION, IT IS LIKELY THAT THE PATIENT ANATOMY (MILDLY CALCIFIED ARTERY) CONTRIBUTED TO THE EVENT. ACCORDING TO THIS INVESTIGATION, NO EVIDENCE COULD BE FOUND WHICH SUPPORTS THE ASSUMPTION THAT A DEVICE DEFECT LED TO PROBLEMS DESCRIBED IN THE CASE DESCRIPTION. WHILE A DEFINITIVE CAUSE CANNOT BE DETERMINED IN THIS INCIDENT, NO PRODUCT MALFUNCTION, FAILURE OR DETERIORATION OF CHARACTERISTIC OR PERFORMANCE OF THE DEVICE OR INADEQUACY IN THE LABELING AND/OR IFU WAS IDENTIFIED. A REVIEW OF THE LOT HISTORY RECORD FOR THIS DEVICE DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED THAT THEY RECEIVED CUVETTE NOT DRY ERRORS ON SYNCHRON LX I 725 CLINICAL SYSTEM. WHEN TROUBLESHOOTING, THE CUSTOMER NOTICED DROPS OF FLUID ON TOP OF THE REAGENT CAROUSEL COVER. NO INJURY HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS DE NOVO SUPERFICIAL FEMORAL ARTERY WITH MILD CALCIFICATION. DURING THE FIRST INFLATION AT 10 ATMOSPHERE (ATM) THE FOX PLUS BALLOON RUPTURED. A NON-ABBOTT SAME SIZE BALLOON CATHETER WAS USED IN THE PROCEDURE. THERE WAS NO REPORTED PT EFFECT. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOX PLUS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT ABBOTT VASCULAR NA 583016

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDE WIRE: RADIFOCUS