BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 3023403 · Received March 27, 2013

    Report

    Report Number
    2024168-2013-01752
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 4, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ABBOTT ANALYZED THE RETURNED DEVICE AND CONFIRMED THE REPORTED LEAK. A REVIEW OF THE COMPLAINT HANDLING DATABASE FOUND NO SIMILAR INCIDENTS FROM THIS LOT. ABBOTT IDENTIFIED THE ROOT CAUSE OF THE LEAK, AND WILL IMPLEMENT CORRECTIVE ACTIONS TO PREVENT RECURRENCE OF THIS ISSUE PER SITE PROCEDURES.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. BOTH ARMADA 14 DEVICES HAD BEEN PREPARED PER THE IFU BEFORE USE AND DURING THESE PREPARATIONS NO DAMAGE ON BOTH ARMADA 14 CATHETERS WERE NOTICED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE ADDITIONAL ARMADA 14 DILATATION CATHETER MENTIONED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. CONCOMITANT PRODUCTS: GUIDE WIRE: WINN 40, INFLATION: SWISS MEDICAL PRESSURE MANOMETER , SHEATH: 5 FR. CORDIS. THE DEVICE WAS RECEIVED. 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 DURING THE PROCEDURE, A 1.5MM X 120MM X 90CM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS INTRODUCED VIA FEMORAL ACCESS OVER A WINN 40 GUIDE WIRE AND INTO A 5FR NON-ABBOTT SHEATH, ADVANCED VIA ANTEGRADE APPROACH, THEN WAS POSITIONED SUCCESSFULLY IN THE MODERATELY CALCIFIED, DE NOVO, 95% STENOSED LESION IN THE NARROW PROXIMAL POSTERIOR TIBIAL ARTERY, HOWEVER, WHEN ATTEMPTING TO INFLATE THE ARMADA 14 BDC, THE BALLOON DID NOT INFLATE AT ALL; NO BALLOON RUPTURE AND NO LEAKING OF CONTRAST IN THE VESSEL WAS OBSERVED. THE ARMADA 14 BDC WAS WITHDRAWN FROM THE ANATOMY WITHOUT RESISTANCE AND ANOTHER 1.5MM X 120MM X 90CM ARMADA 14 BDC WAS ADVANCED AND POSITIONED SUCCESSFULLY IN THE SAME LESION. AGAIN, WHEN ATTEMPTING TO INFLATE THE 2ND ARMADA 14 BDC, THE BALLOON DID NOT INFLATE AT ALL; NO BALLOON RUPTURE AND NO LEAKING OF CONTRAST IN THE VESSEL WAS OBSERVED IN THIS DEVICE, AS WELL. THE 2ND ARMADA 14 BDC WAS ALSO WITHDRAWN FROM THE ANATOMY WITHOUT RESISTANCE. A NON-ABBOTT BDC WAS USED TO SUCCESSFULLY COMPLETE DILATATION OF THE LESION, RESULTING IN 10% LESION STENOSIS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. AFTER REMOVAL FROM THE ANATOMY, BOTH ARMADA 14 DEVICES WERE INSPECTED WHILE FLUSHING THE DEVICES WITH CONTRAST MEDIA: CONTRAST WAS NOTED TO BE LEAKING OUT OF THE GUIDE WIRE PORT ON THE HUB OF EACH DEVICE. REPORTEDLY, THE PHYSICIAN SUSPECTS THERE IS A CONNECTION / OPENING TO THE GUIDE WIRE LUMEN INSIDE THE ARMADA 14 CATHETERS THAT CAUSES THE CONTRAST MEDIA TO FLOW IN THE WRONG DIRECTION, MAKING THE INFLATION IMPOSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126695 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 722191

    Patients

    Seq Age Sex Outcome Treatment
    1