BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 3103080 · Received May 9, 2013

    Report

    Report Number
    2024168-2013-02909
    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. CONCOMITANT MEDICAL PRODUCTS: HT CONNECT; SHEATH: CORDIS 5F BRITE TIP. 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. THE LEAK WAS CONFIRMED AS THERE WAS A BALLOON RUPTURE. FOREIGN MATERIAL ON THE DEVICE (CONTAMINATION) WAS NOT CONFIRMED. BASED ON VISUAL 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 MODERATELY CALCIFIED, MODERATELY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY. THE 4X120 MM FOXCROSS CATHETER WAS POSITIONED IN THE TARGET LESION SUCCESSFULLY; HOWEVER, DURING THE ATTEMPT TO INFLATE THE BALLOON, LEAKING WAS OBSERVED OUT OF THE BALLOON CATHETER. THE BALLOON DID NOT INFLATE AT ALL. IT WAS STATED THAT DURING RETRACTION OF THE BALLOON CATHETER FROM THE ANATOMY, FOREIGN MATERIAL WAS OBSERVED ON THE OUTSIDE OF THE MIDDLE PART OF THE FOXCROSS BALLOON. THE TARGET LESION WAS FINALLY TREATED WITH A NEW FOXCROSS 4.0X120MM WITHOUT ANY ISSUES. THE RESULT WAS SATISFACTORY, THERE WERE 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
    203653 FOXCROSS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 803309

    Patients

    Seq Age Sex Outcome Treatment
    1