BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2141653 · Received June 27, 2011

    Report

    Report Number
    2024168-2011-04496
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 30, 2011
    Report Date
    May 31, 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. FACTORS THAT CAN CONTRIBUTE TO DIFFICULTY POSITIONING/REMOVING THE CATHETER (RESISTANCE) WITHIN THE GUIDING CATHETER INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, LOOSE BALLOON FOLDS, GUIDING CATHETER LUMEN OBSTRUCTIONS, KINKS, BENDS, LESION TORTUOSITY AND CALCIFICATION, PROCEDURAL TECHNIQUE, INSUFFICIENT SUPPORT OR INTERACTIONS WITH OTHER DEVICES. IN THIS CASE, NO PATIENT ANATOMICAL INFORMATION WAS PROVIDED AND THE DEVICES OR USED GUIDING CATHETERS WERE NOT RETURNED FOR ANALYSIS, ALL OF WHICH MAY HAVE AIDED THE INVESTIGATION. IT IS POSSIBLE THAT IF THERE ARE MULTIPLE DEVICES WITHIN THE GUIDING CATHETER, THIS CAN CONTRIBUTE TO DIFFICULTY ADVANCING AND REMOVING THE DEVICE. BASED ON THE LIMITED INFORMATION RECEIVED WITH THIS INCIDENT AND WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE COULD NOT BE DETERMINED. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS NOT PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE PART/LOT NUMBERS WERE NOT REPORTED.

    Description of Event or Problem · 1

    A GENERAL REPORT WAS RECEIVED THAT AN UNDOCUMENTED NUMBER OF INCIDENTS HAVE OCCURRED INVOLVING THE TREK BALLOON, THAT WHEN USING THEM ON COMPLEX PROCEDURES, LIKE KISSING BALLOON, THE PROXIMAL SHAFT IS TOO BIG AND RESISTANCE IS FELT IN THE GUIDING CATHETER DURING ADVANCEMENT AND RETRACTION WHEN MORE THAN ONE DEVICE IS BEING USED (SDS). ALTHOUGH REQUESTED, NO SPECIFIC EVENT INFORMATION WAS RECEIVED. THE CUSTOMER DID REPORT THAT THERE WERE NO ADVERSE EVENTS AT ANY TIME. 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