BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 3103105 · Received May 9, 2013

    Report

    Report Number
    2024168-2013-02910
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. DIFFICULT TO POSITION GUIDE WIRE AND DIFFICULT TO REMOVE GUIDE WIRE WERE NOT CONFIRMED. BASED ON VISUAL, DIMENSIONAL, AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RESTENOSED, MID FEMORAL ARTERY, THAT WAS MILDLY TORTUOUS AND MODERATELY CALCIFIED. WHEN TRYING TO ADVANCE A NON-ABBOTT GUIDE WIRE THROUGH THE FOXCROSS 5.0 X 120 MM BALLOON DILATATION CATHETER GUIDE WIRE LUMEN, RESISTANCE WAS FELT. DURING RETRACTION OF THE GUIDE WIRE, RESISTANCE WAS ALSO FELT; HOWEVER, THE GUIDE WIRE WAS ABLE TO BE REMOVED FROM THE FOXCROSS CATHETER SUCCESSFULLY. THE PHYSICIAN FURTHER COMMENTED THAT HE BELIEVES THE RESISTANCE WAS DUE TO THE COAGULATION OF BLOOD ON THE GUIDE WIRE AND IN THE LUMEN OF THE CATHETER. THE END RESULT WAS FINE WITH NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203013 FOXCROSS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 811040

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: CORDIS EMERALD