BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY RX

    MDR report key: 2864085 · Received December 10, 2012

    Report

    Report Number
    9612164-2012-01758
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 10, 2012
    Report Date
    November 11, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: RELATED TO OPERATIONAL CONTEXT -THE RESIDUE WAS INTRODUCED INTO THE GUIDE WIRE LUMEN POST REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. CONCLUSIONS: RELATED TO OPERATIONAL CONTEXT -THE RESIDUE WAS INTRODUCED INTO THE GUIDE WIRE LUMEN POST REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO ADVANCE AN INTEGRITY STENT TO A LESION BUT IT WAS STUCK INSIDE THE GUIDES. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE GUIDEWIRE WHICH WAS BEEN USED TO PROTECT THE SIDE BRANCH BUT IT GOT STUCK WITH THE DEVICE AND WHEN WITHDRAWING THE DEVICE THE SHAFT BROKE; THE PHYSICIAN USED ANOTHER DEVICE TO TREAT THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: THE TRANSITION SHAFT WAS STRETCHED AND KINKED. THE TRANSITION SHAFT HAD DETACHED IMMEDIATELY PROXIMAL TO THE GUIDEWIRE ENTRY PORT. THE SHAFT WAS STRETCHED AND JAGGED ON BOTH SIDE OF THE DETACHMENT SIT. THE DISTAL SECTION OF THE DEVICE WAS STUCK ON THE PROCEDURAL GUIDEWIRE. THE DISTAL OUTER AND INNER SHAFTS WERE CUT BACK AT THE GUIDEWIRE ENTRY PORT TO EXPOSE THE GUIDEWIRE. THE DISTAL SHAFT WAS THEN REMOVED FROM THE GUIDEWIRE. VISUAL INSPECTION CONFIRMED THE PRESENCE OF RESIDUE ALONG THE GUIDEWIRE AND INSIDE THE INNER SHAFT. A 0.014" PATENCY MANDREL WAS INSERTED IN TO THE DISTAL TIP AND ADVANCED ALONG THE UNCUT SECTION OF THE INNER LUMEN. A WHITE CRYSTALLIZED RESIDUE WAS REMOVED FROM THE INNER DURING ADVANCEMENT OF THE MANDREL. THE DISTAL TIP WAS FLARED AND DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY RX STENT, CORONARY MAF MEDTRONIC IRELAND 0005837210

    Patients

    Seq Age Sex Outcome Treatment
    1