BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINTER LEGEND RX BALLOON DILATATION CATHETER

    MDR report key: 2100470 · Received May 17, 2011

    Report

    Report Number
    9612164-2011-00429
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 19, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    LOX
    PMA / PMN Number
    KI03095
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS, CONCLUSIONS: SEVERELY CALCIFIED, NARROW LESION, 80-90% STENOSIS REMAINING FOLLOWING PRE-DILATION. EVAL SUMMARY: THE DEVICE WAS RETURNED TO THE MFG FACILITY FOR EVAL. THE INNER TUBING HAD DETACHED 22CM DISTAL TO THE GUIDE WIRE ENTRY PORT BOND. THE BALLOON HAD TORN RADIALLY 13MM DISTAL TO THE PROXIMAL BALLOON BOND. THE TEAR APPEARS TO HAVE CONTINUED IN A RADIAL PATTERN UNTIL THE BALLOON SEPARATED. THE REMAINDER OF THE BALLOON, THE INNER TUBING, INNER SHAFT MARKER AND THE TIP DETACHED FROM THE DEVICE. PROCEDURAL IMAGES WERE PROVIDED FOR REVIEW. THE PROCEDURAL IMAGES CONFIRMED THE DIFFICULT NATURE OF THE LESION. THE CD CONTAINED IMAGES OF A BALLOON INFLATED AT THE LESION. IMAGES SHOWING THE DETACHMENT OR THE DETACHED MATERIAL IN THE VESSEL WERE NOT CAPTURED.

    Description of Event or Problem · 1

    A SPRINTER LEGEND RAPID EXCHANGE (RX) BALLOON DILATATION CATHETER WAS USED TO TREAT A NARROW, SEVERELY CALCIFIED LESION WITH 80-90% STENOSIS FOLLOWING PRE-DILATION, IN THE MID LAD. SOME RESISTANCE WAS ENCOUNTERED DURING INSERTION OF THE SPRINTER LEGEND BALLOON. THE DEVICE WAS SUCCESSFULLY INFLATED ONCE TO 10 ATMS AND WAS THEN DEFLATED. WHEN AN ATTEMPT WAS MADE TO REMOVE THE BALLOON, PART OF THE BALLOON MATERIAL DETACHED AND REMAINED WITHIN THE LESION. THE PT WAS REFERRED FOR CABG SURGERY. DURING THE SURGERY, DUE TO IMPAIRED FLOW IN LAD AND D1, THE PT REQUIRED ADMINISTRATION OF INTEGRILIN, INTUBATION, PARTIAL EXTERNAL HEART MASSAGE AND INCREASE OF CATECHOLAMINES. THE DETACHED MATERIAL WA NOT REMOVED DURING THE SURGERY DUE TO UNFAVORABLE ANATOMICAL CONDITIONS. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. THE PT REMAINS IN HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINTER LEGEND RX BALLOON DILATATION CATHETER LOX MEDTRONIC IRELAND NA 0005484524

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention