BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2182342 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05375
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE 3.0 X 12 GRAFTMASTER IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF PERFORATION, AS LISTED IN THE RX TREK INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY ANGIOPLASTY PROCEDURES. PERFORATIONS CAN BE INFLUENCED BY SEVERAL FACTORS INCLUDING, BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED; THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SAPHANEOUS VEIN GRAFT TO RIGHT CORONARY ARTERY PROCEDURE, AFTER PRE-DILATATION WITH A TREX RX DILATATION CATHETER, A PERFORATION WAS NOTED ON ANGIOGRAPHY. A GRAFTMASTER 3.0 X 12 DID NOT CROSS THE TORTUOUS LESION. THE DEVICE WAS REMOVED AND AN ADDITIONAL 3.0 X 16 GRAFTMASTER CROSSED THE LESION AND SEALED THE PERFORATION. POST PROCEDURE, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT. THE PATIENT'S CONDITION RESOLVED AND THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2011, THREE DAYS AFTER THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1020161

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R