BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 3190293 · Received June 26, 2013

    Report

    Report Number
    2024168-2013-03979
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 3, 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 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 ANALYSIS. THE RUPTURE WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL INSPECTION AND SCANNING ELECTRON MICROSCOPY 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION WITH 90% STENOSIS IN THE SUPERFICIAL FEMORAL ARTERY USING A CONTRALATERAL FEMORAL APPROACH. A 7X100X80 FOXCROSS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED ON THE FIRST INFLATION BELOW THE NOMINAL PRESSURE OF 6 ATMOSPHERES. IT IS UNKNOWN HOW THE TARGET LESION WAS ULTIMATELY TREATED; HOWEVER, THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289593 FOXCROSS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 662926

    Patients

    Seq Age Sex Outcome Treatment
    1