BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 3051470 · Received April 10, 2013

    Report

    Report Number
    2024168-2013-02188
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 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 REPORTED BALLOON RUPTURE WAS CONFIRMED. BASED ON VISUAL AND SCANNING ELECTRON MICROSCOPY (SEM) IMAGING ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. BASED ON THE REPORTED INFORMATION, MANUFACTURING INSPECTION CRITERIA AND ANALYSIS OF THE RETURNED DEVICE, PROBABLE CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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 MODERATELY TORTUOUS, MODERATELY CALCIFIED, 99% STENOSIS LESION. THE FOX CROSS WAS DELIVERED AND INFLATED; HOWEVER, IT RUPTURED AT THE FIRST INFLATION AT 12 ATMOSPHERES. THERE WAS NO RESISTANCE ADVANCING OR REMOVING THE BALLOON CATHETER. A NON-ABBOTT STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148527 FOXCROSS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 770404

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: RADIFOCUS