BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2060260 · Received April 15, 2011

    Report

    Report Number
    2024168-2011-02669
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED TREK DILATATION CATHETER NOTED BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN AND IN THE LOOSELY FOLDED BALLOON, CONSISTENT WITH PREPARATION AND A RUPTURE WHILE IN THE PATIENT ANATOMY. THERE WAS A BEND IN THE HYPOTUBE 17 CM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE BEND MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. A NEW INDEFLATOR, FILLED WITH WATER, WAS USED TO PRESSURIZE THE BALLOON WHEN FLUID WAS OBSERVED LEAKING FROM A FLAP RUPTURE OVER THE PROXIMAL MARKER. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING PROCESSING OF THE BALLOON MATERIAL, MATERIALS, INFLATION TECHNIQUE, INTERACTIONS WITH OTHER DEVICES, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION AND TORTUOSITY OR INSUFFICIENT PREPARATION PRIOR TO USE. SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS MAY INDICATE THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. ANALYSIS NOTED A FLAP OF TORN BALLOON MATERIAL. DAMAGE OF THIS TYPE CAN BE THE RESULT OF MATERIAL PROCESSING OR INCORRECT PREPARATION FOR USE. IT WAS REPORTED THE BALLOON WAS SOAKED PRIOR TO USE; HOWEVER, IT IS POSSIBLE THE BALLOON WAS NOT SOAKED FOR A SUFFICIENT AMOUNT OF TIME. IT IS POSSIBLE THAT THE HYDROPHILIC COATING ON THE BALLOON WAS NOT SUFFICIENTLY ACTIVATED UPON EXPOSURE TO MOISTURE SUCH THAT AS THE BALLOON WAS INFLATED, THE BALLOON MATERIAL TORE AND PEELED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR BALLOON RUPTURES FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TREK BALLOON WAS SOAKED PRIOR TO USE PER THE INSTRUCTIONS FOR USE. THE BALLOON RUPTURED WHEN INFLATED IN A SOFT LESION AT 10 ATMOSPHERES. NO PATIENT EFFECTS WERE REPORTED. 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 0092962

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR