BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 3111555 · Received May 14, 2013

    Report

    Report Number
    2024168-2013-03030
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE INFLATION ISSUES WERE ABLE TO BE CONFIRMED DUE TO A BALLOON RUPTURE. BASED ON A VISUAL INSPECTION AND SCANNING ELECTRON MICROSCOPY (SEM) IMAGING 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    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: GUIDE WIRE: 0.035 GUIDE WIRE; SHEATH: CORDIS BRITE 7F. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN OCCLUSION INVOLVING BOTH ILIAC ARTERIES AND THE LOWER PART OF THE AORTA. THE TARGET LESION WAS MODERATE CALCIFIED. A 7F SHEATH WAS PLACED BILATERALLY, AND ACCESS WITH A 0.035 GUIDE WIRE WAS MADE BILATERALLY. THE 50/60 MM FOX PLUS BALLOON CATHETER WAS ADVANCED TO PRE-DILATE FROM THE RIGHT ACCESS OF THE AORTA AND THE RIGHT ILIAC; HOWEVER, IT WAS NOT POSSIBLE TO INFLATE THE FOX PLUS BALLOON UP TO ITS DESIGNED DIAMETER. THERE WAS NO RESISTANCE FELT WHILE TRYING TO INFLATE. THE FOX PLUS BALLOON CATHETER WAS RETRACTED FROM THE ANATOMY WITHOUT ANY ISSUE AND WAS REPLACED WITH A NON-ABBOTT BALLOON CATHETER TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212802 FOX PLUS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 805051

    Patients

    Seq Age Sex Outcome Treatment
    1