BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN PERFORMA STRAIGHT MRI SURESCAN

    MDR report key: 4162333 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12827
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    October 8, 2013
    Report Date
    February 18, 2022
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY - THE FULL LEAD WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE STYLET /GUIDEWIRE WAS BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE GUIDEWIRE WAS PROLAPSING ON ITSELF SO THE GUIDEWIRE WAS REMOVED AND REPLACED AND UPON INSPECTION APPEARED TO BE "STRETCHED OUT". WITH THE REPLACEMENT GUIDEWIRE THE LEAD GUIDEWIRE TIP BROKE OFF WITHIN THE LEFT VENTRICULAR (LV) LEAD BODY. AFTER ACCESS TO THE CORONARY SINUS WAS OBTAINED, THE LV LEAD WITH A HYBRID GUIDEWIRE INSERTED THROUGH THE LEAD ENDED UP WITH THE GUIDEWIRE STUCK IN THE LEAD TIP. UPON PULLING BACK, THE GUIDEWIRE GAVE WAY AND IT WAS EVIDENT UPON REMOVAL OF THE GUIDEWIRE THAT THE TIP BROKE OFF. THE LV LEAD WAS REMOVED AND A GUIDEWIRE COULD NOT BE PASSED THROUGH THE LEAD TIP, SUGGESTING THAT PART OF THE GUIDEWIRE WAS BROKEN OFF WITHIN THE LEAD. CINEANGIOGRAPHY OF THE LUNGS AND HEART IN MULTIPLE MAGNIFIED VIEWS WERE UNABLE TO SEE ANY EVIDENCE OF THE TIP OF THE GUIDEWIRE HAVING DISLODGED WITHIN THE VENOUS SYSTEM OR BEING WITHIN THE LUNG PARENCHYMA. THE LV LEAD WAS NOT IMPLANTED AND ANOTHER MODEL LV WAS ATTEMPTED, BUT IT APPEARED THE LV LEAD WAS GOING TO BE LIMITED BY PHRENIC NERVE CAPTURE. THE SECOND LV LEAD WAS REMOVED AND ANOTHER MODEL LV LEAD WAS IMPLANTED. IT WAS NOTED THE PATIENT WAS PART OF THE ATTAIN PERFORMA CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639197 ATTAIN PERFORMA STRAIGHT MRI SURESCAN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P OJX MPRI 439888

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Male