BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 35 PTA CATHETER

    MDR report key: 12869073 · Received November 24, 2021

    Report

    Report Number
    2024168-2021-10788
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    November 2, 2021
    Report Date
    January 14, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    LIT
    UDI-DI
    08717648155185
    PMA / PMN Number
    K111899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL AND FUNCTIONAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE LEAK WAS NOT 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 OF THE REPORTED LOT REVEALED NO OTHER COMPLAINTS REPORTED FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO CONFIRM THE REPORTED LEAK DURING FUNCTIONAL TESTING OF THE RETURNED UNIT. IT MAY BE POSSIBLE THAT THERE WAS A FAULTY CONNECTION WITH THE SYRINGE OR INFLATION DEVICE, RESULTING IN THE LEAK; 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.B5. REVISED CASE DESCRIPTION. D4. CATALOG NO. PART/NUMBER CHANGED FROM B2050-060, 10712G1 TO B1050-040, 10727G1

    Additional Manufacturer Narrative · 0

    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 · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, THE FOLLOWING CLARIFIED INFORMATION WAS PROVIDED: IT WAS REPORTED THAT DURING PREPARATION OF THE 5.0 X 40 MM ARMADA 35 BALLOON CATHETER, AN AIR LEAK WAS NOTED. THEREFORE, THE BALLOON CATHETER WAS NOT USED AND EXCHANGED FOR A NEW ARMADA 35 BALLOON CATHETER. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREPARATION OF THE 5.0 X 60 MM ARMADA 35 BALLOON CATHETER, AN AIR LEAK WAS NOTED. THEREFORE, THE BALLOON CATHETER WAS NOT USED AND EXCHANGED FOR A NEW ARMADA 35 BALLOON CATHETER. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766325 ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT ABBOTT VASCULAR B2050-060 10727G1 08717648155185

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown