BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 8364861 · Received February 24, 2019

    Report

    Report Number
    2024168-2019-01387
    Event Type
    Malfunction
    Date Received
    February 24, 2019
    Date of Event
    February 1, 2019
    Report Date
    March 19, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL FILE NUMBER (B)(4). CORRECTION: SIZE OF THE REPORTED ARMADA HAS BEEN CORRECTED TO A 2.0X120 CORRECTION: PART NUMBER CHANGED FROM A2015-040 TO A2020-120. CORRECTION: LOT NUMBER CHANGED FROM 8012241 TO 7080941. EVALUATION SUMMARY: VISUAL AND FUNCTIONAL INSPECTIONS WERE PERFORMED, AND THE REPORTED BALLOON RUPTURE WAS CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED/NOTED BALLOON RUPTURE AND BALLOON SCRATCHES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED MDR REPORT, THE CORRECT ARMADA 14 SIZE IS 2.0X120MM. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 PERFORMED TO TREAT A CONCENTRIC LESION IN THE MID FEMORAL ARTERY WITH HEAVY TORTUOSITY, HEAVY CALCIFICATION, THROMBUS, AND 90% STENOSIS. A 1.5X40MM ARMADA 14 PTA CATHETER WAS ADVANCED AND INFLATED HOWEVER DID NOT PROPERLY MAINTAIN AT THE RATED BURST PRESSURE (RBP). THERE WAS NO RESISTANCE NOTED DURING ADVANCEMENT. A BALLOON RUPTURE OCCURRED AT 14 ATMOSPHERES BECAUSE OF THE HEAVY CALCIUM AT THE LESION. A NEW SAME SIDE ARMADA WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158318 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 7080941

    Patients

    Seq Age Sex Outcome Treatment
    1