BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER LEGEND RX BALLOON DILATATION CATHETER

    MDR report key: 2043287 · Received February 25, 2011

    Report

    Report Number
    2953200-2011-00516
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 29, 2011
    Report Date
    January 31, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL, RESULTS & CONCLUSION: (DEVICE LOCKED ON WIRE AND DAMAGE RESULTED). EVAL SUMMARY: A CLEAR LIQUID AND BLOOD RESIDUE WERE PRESENT INSIDE THE INFLATION LUMEN. THE BALLOON BOND WAS STRETCHED. THE BALLOON WAS PARTIALLY INFLATED. THE TIP SEAL HAD BECOME DETACHED AT THE DISTAL SIDE OF THE TIP SEAL BOND. THE DEVICE WAS PLACED IN A WATER BATH TO DISPERSE THE HARDENED CONTRAST TO FACILITATE BALLOON INFLATION. FOLLOWING 24 HOURS IN THE WATER BATH THE DEVICE WAS STILL NOT ABLE TO INFLATE. LIQUID WAS MOVING UP ALONG THE DISTAL SHAFT BUT IT COULD NOT INFLATE BALLOON DUE TO THE STRETCHING.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO USE A SPRINTER LEGEND RAPID EXCHANGE BALLOON DILATATION CATHETER 2MM DIAMETER 15MM LENGTH. THE FIRST AND SECOND INFLATION AND DEFLATIONS WERE SUCCESSFUL. ON THE THIRD DILATATION ATTEMPT, THE BALLOON WOULD NOT FULLY DEFLATE. THE DEVICE WAS REMOVED FROM THE BODY THROUGH A GUIDING CATHETER. DEFLATION WAS ATTEMPTED IN VITRO BUT FAILED AGAIN. THE TIP OF THE DEVICE WAS DETACHED. THE PHYSICIAN REPORTED NO POSSIBILITY OF THE TIP FRAGMENT REMAINING IN THE PT. IT IS REPORTED THAT HEPARIN AND SALINE WERE MISTAKENLY FILLED IN THE INFLATION LUMEN BEFORE THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINTER LEGEND RX BALLOON DILATATION CATHETER LOX MEDTRONIC CARDIOVASCULAR GALWAY NA 10873461

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK