BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2120568 · Received June 10, 2011

    Report

    Report Number
    2024168-2011-04119
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 17, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. POSSIBLE CAUSES FOR DIFFICULTY REMOVING A DILATATION CATHETER AFTER INFLATION MAY INCLUDE: INTERACTION OF THE BALLOON WITH A STENT IMPLANT IF THE STENT IS NOT FULLY EXPANDED AND APPOSED TO THE VESSEL WALL, THE BALLOON NOT BEING FULLY DEFLATED PRIOR TO ATTEMPTING TO REMOVE THE BALLOON FROM THE IMPLANTED STENT, DAMAGE TO THE BALLOON, KINKS, BENDS, OBSTRUCTIONS IN THE GUIDING CATHETER LUMEN, DAMAGE TO THE GUIDING CATHETER OR INTRODUCER SHEATH. ADDITIONALLY, BALLOON REFOLD ISSUES CAN ALSO BE RELATED TO MULTIPLE/HIGH PRESSURE INFLATIONS, INTERACTIONS WITH THE DEPLOYED STENT OR ANATOMY, OR AN INTERACTION WITH THE GUIDING CATHETER. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR INCIDENT QUERY WAS NOT PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE PART AND THE LOT NUMBERS WERE NOT REPORTED. IN THIS CASE, WITHOUT THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. WITHOUT THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. TO HELP ENSURE THIS DIFFICULTY IS NOT RELATED TO A MANUFACTURING DEFICIENCY, THE PROFILE DIMENSIONS ON ALL BALLOON CATHETERS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE.

    Description of Event or Problem · 1

    THIS REPORT IS FOR A GENERAL COMMENT ON THE TREK CORONARY DILATATION CATHETER BY A PHYSICIAN LOCATED AT SAHLGRENSKA UNIVERSITY HOSPITAL IN SWEDEN, WHO HAS EVALUATED THE TREK CORONARY DILATATION CATHETER IN PRE-TENDER EVALUATIONS. IN THE PHYSICIANS OPINION, THE TREK CORONARY DILATATION CATHETER HAD A HIGH POST-DILATATION PROFILE AND A POOR BALLOON RE-WRAP AND RESISTANCE IS EXPERIENCED WHEN RETRACTING THE DEVICE THROUGH THE GUIDING CATHETERS AFTER PROCEDURES. NO PATIENT EFFECTS WERE REPORTED RELATED TO THESE EXPERIENCES; HOWEVER, NO SPECIFIC INFORMATION WAS PROVIDED REGARDING PATIENT INFORMATION OR CASE INFORMATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1