BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 3803192 · Received May 9, 2014

    Report

    Report Number
    2024168-2014-02972
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND THE REPORTED DAMAGE WAS NOT CONFIRMED. BASED ON A VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT THAT WAS RETURNED DOES NOT MATCH THE DAMAGE REPORTED AND FOLLOW-UP TO THE ACCOUNT SUSPECTS THAT THE WRONG DEVICE WAS RETURNED. THEREFORE, THE LOT NUMBER THAT WAS REPORTED AND NOTED ON THE PACKAGING WAS NOT LIKELY FROM THE REPORTED DEVICE. IT SHOULD BE NOTED THAT THE ARMADA 14 INSTRUCTION FOR USE (IFU) STATES: THE DEVICE IS INDICATED TO DILATE STENOSES IN FEMORAL, POPLITEAL, INFRA POPLITEAL AND RENAL ARTERIES AND FOR THE TREATMENT OF OBSTRUCTIVE LESIONS OF NATIVE OR SYNTHETIC ARTERIOVENOUS DIALYSIS FISTULAE. THE 2.0 TO 4.0 MM BALLOON DIAMETERS ARE ALSO INDICATED FOR POST-DILATATION OF BALLOON-EXPANDABLE STENTS UP TO 40 MM AND SELF-EXPANDING STENTS UP TO 80 MM IN THE VESSELS LISTED ABOVE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4) - INDICATION FOR USE. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED NOTES THE RETURNED DEVICE MAY NOT BE THE REPORTED DEVICE; THE LOT NUMBER WAS NOT IDENTIFIED BY THE SITE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A RIGHT FEMORAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE DISTAL ANTERIOR TIBIAL ARTERY THE 2.5 X 200 MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS USED SUCCESSFULLY INFLATED TWICE AT 8 ATMOSPHERE (ATM) AND REMOVED FROM THE ANATOMY WITHOUT REPORTED ISSUE. OUTSIDE THE ANATOMY PRIOR TO RE-USE IT WAS NOTED THAT THE BALLOON MATERIAL APPEARED FLIMSY AND THE INNER MEMBER WAS STRETCHED AND THE ORANGE SHAFT WAS NOT STABLE; THE DEVICE WAS NOT USED AGAIN. THERE WAS NO RESISTANCE NOTED DURING ADVANCING OR REMOVAL. A DIFFERENT BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281931 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 767052

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR GUIDE WIRE: VIPER