BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 3193359 · Received June 27, 2013

    Report

    Report Number
    2024168-2013-04024
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE DEFLATION DIFFICULTIES WERE UNABLE TO BE CONFIRMED. THE PHYSICAL RESISTANCE AND DIFFICULTIES REMOVING THE DEVICE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: NEXUS14 PL-X, CHEVALIER FLOPPY, ASTATO XS9-12; GUIDE CATH: PROMINENT, PALENTPLUS. THE DEVICE WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTALLY OCCLUDED AND HEAVILY CALCIFIED ANTERIOR TIBIAL ARTERY. THE 2.5X120 MM ARMADA BALLOON CATHETER MET RESISTANCE DURING ADVANCEMENT; HOWEVER, REACHED THE LESION AND WAS INFLATED TWELVE TIMES IN TOTAL TO 10 ATMOSPHERES; HOWEVER, AFTER INFLATION, THE BALLOON WOULD ONLY SLIGHTLY DEFLATE. THE BALLOON CATHETER WAS RETRACTED; HOWEVER, THE BALLOON WOULD NOT ENTER THE SHEATH. AFTER SEVERAL ATTEMPTS TO DEFLATE THE BALLOON, THE BALLOON WAS FULLY DEFLATED AND THE BALLOON CATHETER WAS SUCCESSFULLY RETRACTED FROM THE PATIENT. A NON-ABBOTT BALLOON CATHETER WAS USED FOR FURTHER PREDILATATION AND A STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293728 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 769012

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR