BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACIFIC XTREME

    MDR report key: 3831798 · Received May 27, 2014

    Report

    Report Number
    3004066202-2014-00081
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K103464
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: NONE (NO DEVICE RETURN); NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (NO DEVICE OR CINE IMAGES RECEIVED FOR EVALUATION); (BASED ON THE INFORMATION AVAILABLE NO ROOT CAUSE CAN BE DETERMINED). CONCLUSION: UNABLE TO CONFIRM COMPLIANT (NO DEVICE OR CINE IMAGES RECEIVED FOR EVALUATION); (BASED ON THE INFORMATION AVAILABLE NO ROOT CAUSE CAN BE DETERMINED). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A PACIFIC XTREME PTA BALLOON CATHETER TO TREAT A LESION IN THE DISTAL LEFT SFA REPORTED TO EXHIBIT MODERATE CALCIFICATION, AND LITTLE TORTUOSITY. THE DEVICE WAS REMOVED FROM THE PACKAGING, AND PREPPED AS PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE BALLOON BURST AT 10ATMS ON THE SECOND INFLATION. THE BALLOON FAILED TO INFLATE DUE TO THE BURST; HOWEVER, IT ALSO FAILED TO DEFLATE AFTER ATTEMPTING TO REMOVE THE BALLOON. THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. IT WAS REPORTED THAT THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO PATIENT INJURY OR CLINICAL SEQUELAE WERE REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311208 PACIFIC XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT MEDTRONIC MEXICO 207688171

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR