BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACIFIC XTREME PTA BALLOON CATHETER

    MDR report key: 2172681 · Received July 20, 2011

    Report

    Report Number
    3004066202-2011-00032
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    INVATEC INNOVATIVE TECHNOLOGIES SPA.
    Product Code
    LIT
    PMA / PMN Number
    K103464
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION, RESULTS: (THE ROOT CAUSE OF THE EVENT IS UNDETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE). (PERFORATION). CONCLUSION: NO CONCLUSION CAN BE DRAWN (THE ROOT CAUSE OF THE EVENT IS UNDETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE).

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO USE A PACIFIC XTREME PTA BALLOON CATHETER TO TREAT A LONG DIFFUSE LESION LOCATED IN THE SFA. IT WAS REPORTED THAT THE PACIFIC XTREME DEVICE WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY NOTED. IT WAS REPORTED THAT THE DEVICE WAS ADVANCED TO TARGET LESION AND INFLATED TO 14 ATMS WITH NO ISSUE. HOWEVER IT WAS REPORTED THAT ON REMOVAL, THE PHYSICIAN EXPERIENCED DIFFICULTIES WHEN TRYING TO REMOVE THE DEVICE THROUGH THE INTRODUCER SHEATH. NEGATIVE PRESSURE WAS APPLIED TO THE DEVICE, WHICH ALLOWED THE DEVICE TO BE REMOVED FROM THE INTRODUCER SHEATH. IT WAS REPORTED THAT WHEN THE PHYSICIAN CHECKED THE VESSEL, AFTER REMOVAL OF THE PACIFIC XTREME DEVICE, SHE NOTED THAT A SMALL VESSEL PERFORATION HAD OCCURRED. THE PERFORATION WAS TREATED WITH A COVERED STENT. IT WAS REPORTED THAT THE PATIENT WAS FINE POST PROCEDURE AND NO OTHER CLINICAL SEQUELAE WERE REPORTED. IT WAS REPORTED THAT THE PHYSICIAN DID NOT BLAME THE PACIFIC XTREME PTA BALLOON CATHETER FOR THE DAMAGE TO THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACIFIC XTREME PTA BALLOON CATHETER LIT INVATEC INNOVATIVE TECHNOLOGIES SPA. NA 1C002455

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention