BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAGONFLY OPSTAR¿

    MDR report key: 12915958 · Received December 2, 2021

    Report

    Report Number
    3009600098-2021-00024
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 2, 2021
    Report Date
    January 7, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NQQ
    PMA / PMN Number
    K192019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE DRAGONFLY OPSTAR IMAGING CATHETER WAS RECEIVED FOR EVALUATION. THE RESULTS OF THE INVESTIGATION CONCLUDED THAT A LEAK WAS NOTED IN THE PROXIMAL REGION OF THE SHEATH, WHICH IS CONSISTENT WITH THE REPORTED EVENT. FURTHER INVESTIGATION REVEALED THAT THE SHEATH APPEARED TO HAVE A RUPTURE, RESULTING IN A GAP, FROM WHICH THE AFOREMENTIONED LEAK WAS NOTED. THE CAUSE OF THE LEAK IS CONSISTENT WITH THE SHEATH DAMAGE. THE INVESTIGATION IDENTIFIED A POTENTIAL PRODUCT QUALITY ISSUE AND ABBOTT IS PERFORMING FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, THE CATHETER WAS USED IN THE LEFT ANTERIOR DESCENDING ARTERY LESION WITH MODERATE STENOSIS AND TORTUOSITY. THE CATHETER WAS PURGED WITH CONTRAST DURING PREPARATION, AND THE PHYSICIAN FELT AS IF PRESSURE WAS BEING RELEASED FROM THE DEVICE. SINCE THE CONTRAST WAS COMING OUT FROM THE PORT NORMALLY, THE PHYSICIAN ADVANCED THE CATHETER TO THE LESION AND CALIBRATION WAS PERFORMED. HOWEVER, BLOOD AND AIR BEING MIXED INSIDE THE CATHETER WAS VISIBLE ON THE CINE IMAGE. THE CATHETER WAS REMOVED AND PURGED AGAIN. A CRACK WAS FOUND AT THE BLACK PART BETWEEN THE CONNECTION OF THE 3MM SYRINGE PORT AND THE CATHETER. CONTRAST WAS LEAKING FROM THE CRACK. ANOTHER CATHETER WAS USED AND THE PROCEDURE WAS CONTINUED AND COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812621 DRAGONFLY OPSTAR¿ DRAGONFLY OPSTAR IMAGING CATHETER NQQ ABBOTT VASCULAR 1014652 8035684

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown