BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN.PACT PACIFIC

    MDR report key: 8726855 · Received June 24, 2019

    Report

    Report Number
    9612164-2019-02500
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    June 18, 2019
    Report Date
    July 26, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE RETURNED WITH A GUIDEWIRE LOCKED IN THE DEVICE; IT WAS NOT POSSIBLE TO REMOVE THE GUIDEWIRE. THERE WAS A DETACHMENT OF BALLOON MATERIAL. THE REMAINING PROXIMAL BALLOON MATERIAL WAS BUNCHED AND DEFORMED. THE INNER SHAFT MATERIAL WAS SEVERELY STRETCHED BETWEEN THE PROXIMAL BALLOON BOND AND THE DISTAL TIP. THE PROXIMAL BALLOON BOND WAS STRETCHED AND BUNCHED. THE BALLOON MATERIAL WAS JAGGED AND UNEVEN AT THE DETACHMENT SITE. THE DISTAL TIP MATERIAL WAS BUNCHED AND DEFORMED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ¿PLEASE NOTE THAT THIS DEVICE (IN.PACT PACIFIC) IS NOT MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES MARKETED DEVICE (IN.PACT ADMIRAL). THIS EVENT IS BEING REPORTED ONLY AS A MALFUNCTION BECAUSE OF THE SIMILAR DEVICE REQUIREMENT IN 803 WHICH IS LIMITED TO MALFUNCTIONS.¿ IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PHYSICIAN USED AN INPACT PACIFIC DURING TREATMENT OF AN (ARTERIOVENOUS FISTULA). INFLATION DEVICE WAS USED FOR BALLOON INFLATION. IT IS REPORTED DEFLATION DIFFICULTIES WERE EXPERIENCED AT THE DEFLATION SITE. MANY ATTEMPTS WERE MADE TO DEFLATE THE BALLOON. DEFLATION WAS FINALLY ACHIEVED, AND THE BALLOON WAS REMOVED FROM THE PATIENT TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523350 IN.PACT PACIFIC DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU MEDTRONIC IRELAND 0008873831

    Patients

    Seq Age Sex Outcome Treatment
    1