BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 2063080 · Received April 19, 2011

    Report

    Report Number
    2024168-2011-02733
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 25, 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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: 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 BEING INFLATED. DURING FUNCTIONAL TESTING, THE REPORTED RUPTURE WAS CONFIRMED. A NEW INDEFLATOR FILLED WITH WATER WAS USED TO PRESSURIZE THE BALLOON. THERE WAS A PINHOLE IN THE MIDDLE OF THE BALLOON, 9.5 CM PROXIMAL TO THE DISTAL END OF THE BALLOON. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS WAS PERFORMED, AND THE RESULTS SUGGEST THAT THE BALLOON RUPTURE MAY BE ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE OF THE MATERIAL. BASED ON THE REPORTED INFORMATION, THE LESION WAS DESCRIBED AS BEING MODERATELY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE REPORTED RUPTURE. THERE WAS NO REPORTED LEAK NOTED DURING PREPARATION FOR USE, FURTHER SUGGESTING THE DAMAGE OCCURRED DURING USE. IF THE BALLOON EXPERIENCES MECHANICAL DAMAGE DURING THE PROCEDURE, THIS CAN CAUSE THE BALLOON MATERIAL TO WEAKEN AND RUPTURE DURING AN ATTEMPT TO INFLATE THE BALLOON. 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. THE BALLOON RUPTURE APPEARS TO BE RELATED TO MECHANICAL DAMAGE LIKELY INDUCED BY THE CALCIFICATION OF THE LESION. THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RBP AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE IN THE MODERATELY CALCIFIED LEFT POPLITEAL ARTERY, THE BALLOON RUPTURED AT 10 ATMOSPHERES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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 693284

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR