BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 2070437 · Received April 27, 2011

    Report

    Report Number
    2024168-2011-02955
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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. EVALUATION SUMMARY: ANALYSIS NOTED BLOOD IN THE BALLOON, ON THE SHAFT, AND ON THE SIDEARM, CONSISTENT WITH USE OF THE DEVICE IN THE ANATOMY. THE BALLOON APPEARED TO HAVE BEEN INFLATED. THE BALLOON WAS NOTED TO BE RUPTURED LONGITUDINALLY AT THE DISTAL TAPER WITH A SEPARATION NEAR THE DISTAL SHOULDER, CONFIRMING THE REPORTED RUPTURE AND SEPARATION. THE FRACTURE FACE AT THE RUPTURE WAS JAGGED. THE INNER MEMBER WAS SEPARATED, AGAIN CONFIRMING THE SEPARATION. THE INNER MEMBER WAS STRETCHED, LIKELY DUE TO FORCE PLACED ON IT BY THE DISTAL SEPARATED PART OF THE BALLOON GETTING CAUGHT ON THE INTRODUCER SHEATH AS THE DEVICE WAS WITHDRAWN FROM THE PATIENT AND LIKELY LED TO THE INNER MEMBER SEPARATION. THE INNER MEMBER WAS BUNCHED DISTAL AND PROXIMAL TO THE DISTAL MARKER, LIKELY DUE TO THE LOSS OF SUPPORT ONCE THE BALLOON SEPARATED. NO RESISTANCE WAS NOTED, BUT IT IS LIKELY THAT THIS RESISTANCE MAY NOT HAVE BEEN NOTICED AS IT OCCURRED WHILE THE DEVICE WAS BEING REMOVED FROM THE INTRODUCER SHEATH. SCANNING ELECTRON MICROSCOPY ANALYSIS OF THE BALLOON AND INNER MEMBER INDICATED THE BALLOON LIKELY SEPARATED DUE TO MECHANICAL DAMAGE TO THE OUTER SURFACE. AS THE VESSEL WAS REPORTEDLY HEAVILY CALCIFIED, THE BALLOON WAS LIKELY DAMAGED AT THE TIME OF INFLATION BY THE CALCIFICATION PRESENT. IT WAS ALSO NOTED THAT THE INNER MEMBER LIKELY SEPARATED DUE TO TEARING AND MECHANICAL DAMAGE, WHICH MAY AGREE WITH THE LIKELY CAUSE OF DISTAL BALLOON RESISTANCE LEADING TO THE STRETCHING OF THE INNER MEMBER AS THE DEVICE WAS WITHDRAWN FROM THE ANATOMY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. FURTHERMORE, A QUERY OF THE COMPLAINT-HANDLING DATABASE REVEALED NO OTHER COMPLAINTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED. IN MANUFACTURING, ALL BALLOON DILATATION CATHETERS ARE 100% VISUALLY INSPECTED FOR BALLOON DAMAGE, AND INFLATED TO RATED BURST PRESSURE ONLINE. ADDITIONALLY, A SAMPLE OF UNITS FROM EACH LOT IS TAKEN TO RUPTURE AND THE VALUES ARE RECORDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT ILIAC ARTERY. THE FOXCROSS BALLOON RUPTURED DURING THE FIRST INFLATION AT 15 ATMOSPHERES. THERE WAS NO REPORTED RESISTANCE REMOVING THE CATHETER; HOWEVER, ONCE OUTSIDE THE PATIENT, THE BALLOON WAS OBSERVED TO HAVE SEPARATED. THE ENTIRE CATHETER WAS REMOVED ON THE GUIDE WIRE; NO PIECES REMAINED IN THE PATIENT. IT WAS FELT THAT THE LESION WAS OPENED ENOUGH IN THAT AREA, SO NO ADDITIONAL BALLOONING WAS PERFORMED. THERE WAS NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOXCROSS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 686999

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR