BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 2032802 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02114
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. THE BALLOON CATHETER WAS RETURNED WITH BLOOD AND CONTRAST IN THE BALLOON, CONSISTENT WITH A LEAK IN THE ANATOMY. THE BALLOON WAS LOOSELY FOLDED, CONSISTENT WITH THE ATTEMPTED INFLATION. THE PROXIMAL END OF THE BALLOON WAS WRINKLED FOR A LENGTH OF 5 MM. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. DURING FUNCTIONAL TESTING, A NEW INDEFLATOR FILLED WITH WATER WAS USED TO PRESSURIZE THE BALLOON CATHETER. WATER LEAKED OUT OF A SMOOTH RADIAL CUT 2 MM PROXIMAL TO THE BALLOON. THE INNER MEMBER WAS NOT CUT. THE BALLOON COULD NOT BE PRESSURIZED DUE TO THE CUT. POTENTIAL FACTORS THAT COULD CAUSE THIS TYPE OF DAMAGE INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, DAMAGED DURING REMOVAL FROM THE PACKAGING, DAMAGED DURING PREPARATION OR DAMAGED INDUCED BY INTERACTION WITH ASSOCIATED DEVICES. TO ENSURE THIS TYPE OF DAMAGE IS NOT MANUFACTURING RELATED, ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. THERE WAS NO LEAK NOTED DURING PREPARATION, SUGGESTING THAT THE DAMAGE MAY HAVE OCCURRED DURING USE. IT MAY BE POSSIBLE THAT THE DAMAGE IS THE RESULT OF INTERACTION WITH THE ROTATING HEMOSTATIC VALVE (RHV) OR GUIDE CATHETER DURING INSERTION. HOWEVER, THIS COULD NOT BE CONFIRMED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. OVERALL, A CONCLUSIVE CAUSE FOR THE DAMAGE COULD NOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE INVOLVING INTERVENTION OF A PROXIMAL ANTERIOR TIBIAL, THE 2.5 ARMADA BALLOON RUPTURED AT 2 ATMOSPHERES. THIS WAS AFTER A 2.0 BALLOON CATHETER WAS SUCCESSFULLY INFLATED AT THE LESION SITE. THE LESION HAD MODERATE CALCIFICATION. THERE WAS NO PATIENT INJURY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 691008

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR