BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX P3 PTA DILATATION CATHETER

    MDR report key: 1053637 · Received May 27, 2008

    Report

    Report Number
    9610978-2008-00133
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 5, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE POWERFLEX BALLOON WAS INTRODUCED, INFLATED, DEFLATED AND REMOVED SUCCESSFULLY DURING A PTA. THE BALLOON WAS REINTRODUCED A SECOND TIME AND EXPERIENCED DIFFICULTY ON INSERTION THROUGH THE SHEATH INTRODUCER, DIFFICULTY TRACKING TO TARGET LESION AND DIFFICULTY WITHDRAWING THE DEVICE FROM THE SHEATH INTRODUCER. THERE WAS NO REPORTED HARM TO THE PATIENT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THIS REVIEW WAS EXTENDED TO SUBASSEMBLIES, AND CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN AS WELL. SINCE THE PRODUCT OR FILMS OF THE PROCEDURE WILL NOT BE RETURNED, THERE IS NOT ENOUGH INFORMATION TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, THE DIFFICULTIES THE USER EXPERIENCED COULD BE CAUSED BY INCOMPLETE/IMPROPER BALLOON REWRAPPING.

    Description of Event or Problem · 1

    THE POWERFLEX BALLOON WAS ADVANCEDS THROUGH AN UNKNOWN 6F SHEATH INTRODUCE TO THE TARGET LESION AND WITHDRAWN THOUGH THE SHEATH INTRODUCER WITHOUT ANY DIFFICULTY DURING THE INITIAL ADVANCEMENT. ON THE SECOND INSERTION OF THE SAME BALLOON, THERE WAS DIFFICULTY EXPERIENCED ADVANCING THE DEVICE THROUGH THE SHEATH. THERE WERE ALSO PROBLEMS ENCOUNTERED TRACKING THE DEVICE TO THE TARGET LESION. THE PHYSICIAN DECIDED TO DISCONTINUE THE PROCESS AND REMOVE THE DEVICE; HOWEVER, THERE WAS PROBLEMS EXPERIENCED WITHDRAWING THE DEVICE THROUGH THE SHEATH INTRODUCER. FORCE WAS APPLIED TO REMOVE THE DEVICE FROM THE SHEATH. NEGATIVE PRESSURE WAS APPLIED AND THE BALLOON WAS FULLY DEFLATED UPON WITHDRAWAL. THERE WERE NO OBSERVED DAMAGE TO THE BALLOON, AND NO KINKS WERE NOTED. THE DEVICE DID NOT ACCORDION OR SEPARATE DURING REMOVAL. THERE WERE NO NOTED DAMAGE OR KINKS OBSERVED IN THE SHEATH INTRODUCER. THE SAME SHEATH INTRODUCER WAS USED TO COMPLETE THE PROCEDURE. ANOTHER POWERFLEX BALLOON CATHETER WAS SUCCESSFULLY USED. THERE WERE NO PROBLEMS ENCOUNTERED ADVANCING THIS PRODUCT THROUGH THE SHEATH. THERE WAS NO TRACKING DIFFICULTY EXPERIENCED, OR PROBLEMS ENCOUNTERED WITHDRAWING THE DEVICE FROM THE SHEATH INTRODUCER. THE PRODUCT WAS DISCARDED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERFLEX P3 PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA R0807076

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNKNOWN 6F CSI