BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA

    MDR report key: 19996182 · Received August 15, 2024

    Report

    Report Number
    2024168-2024-09658
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    April 18, 2024
    Report Date
    November 26, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    LIT
    UDI-DI
    08717648154621
    PMA / PMN Number
    K111899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED. VISUAL INSPECTION, FUNCTIONAL TESTING, SCANNING ELECTRON MICROSCOPY (SEM) AND CHEM ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED INFLATION ISSUE WAS CONFIRMED, AND A LEAK WAS NOTED ON THE RETUNED DEVICE. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR COMPLAINTS FROM THIS LOT. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, A DEFINITIVE CAUSE FOR THE REPORTED INFLATION ISSUE AND NOTED LEAK COULD NOT BE DETERMINED. THERE WAS NO LEAK NOTED DURING PREPARATION, WHICH SUGGESTS A PRODUCT QUALITY ISSUE DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. ACCORDING TO SEM ANALYSIS NO LEAKAGE OR BLOCKAGES WERE OBSERVED AT THE DISTAL END OF THE LUER. SEM REPORTED THAT CONTAMINATION WAS OBSERVED IN THE BALLOON BETWEEN THE PROXIMAL MARKER AND PROXIMAL BALLOON SEAL. FOURIER TRANSFORM INFRARED SPECTROMETER (FTIR) TESTING WAS PERFORMED TO IDENTIFY THE NOTED CONTAMINATION FOUND AND IT WAS CONCLUDED THE CONTAMINATION COULD BE BLOOD PLASMA/SERUM, THAT COULD BE THE OBSTRUCTION AT SOME POINT OF THE INFLATION PATH. IN THIS CASE, IT IS POSSIBLE THAT THE NOTED CONTAMINATION CONTRIBUTED TO THE REPORTED INFLATION ISSUE; HOWEVER, A CONCLUSIVE CAUSE CANNOT BE DETERMINED. ADDITIONALLY, SEM REPORT SAID THE DEVICE LEAKAGE FROM THE PROXIMAL END OF THE LUER MAY POSSIBLY BE ATTRIBUTED TO GAPS/CHANNELS IN THE ADHESIVE BONDING AREA, BUT IT WAS REPORTED BY THE ACCOUNT THAT THE DEVICE WAS SUBJECTED TO A HIGHER PRESSURE THAT RECOMMENDED OUTSIDE OF THE PATIENT TO SEE IF THE BALLOON INFLATES, THIS HANDLING COULD AFFECT THE ADHESIVE BONDING. IT MAY BE POSSIBLE THAT THE ADHESIVE BONDING WAS COMPROMISED DURING THE MULTIPLE INFLATION ATTEMPTS AND/OR HIGHER-PRESSURE INFLATION AND SUBSEQUENTLY RESULTING IN THE NOTED LEAK DURING RETURN ANALYSIS; HOWEVER, THIS COULD NOT BE CONFIRMED. 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

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 5X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCE TO THE TARGET LESION; HOWEVER, THE BALLOON FAILED TO INFLATE AFTER SEVERAL ATTEMPTS. THE BDC WAS REMOVED FROM THE PATIENT. OUTSIDE OF THE PATIENT ANOTHER ATTEMPT WAS MADE TO INFLATE THE BALLOON AND PRESSURE WAS APPLIED TO 24 ATMOSPHERES (ATM); HOWEVER, THE BALLOON STILL DID NOT INFLATE. ANOTHER ARMADA BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. RETURN DEVICE ANALYSIS FOUND THERE WAS A LEAK NOTED AT 6ATM AT THE PROXIMAL END OF HUB AT GUIDE WIRE PORT. BUBBLES WERE NOTED IN THE GUIDE WIRE PORT WHEN INDEFLATOR WAS PRESSURIZED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618944 ARMADA PERIPHERAL DILATATION CATHETER LIT ABBOTT VASCULAR INC. B1050-080 10226G1 08717648154621

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown