BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2022744 · Received March 17, 2011

    Report

    Report Number
    2024168-2011-01796
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT FOUND BLOOD VISIBLE IN THE LOOSELY FOLDED BALLOON AND INFLATION LUMEN AND CONTRAST ON THE HYPOTUBE, CONSISTENT WITH A LEAK WHILE IN THE PATIENT ANATOMY. A NEW INDEFLATOR, FILLED WITH WATER, WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON TO THE RATED BURST PRESSURE (RBP) OF 14 ATMOSPHERES, WHEN IT WAS OBSERVED THAT FLUID WAS COMING OUT OF THE TIP AND GUIDE WIRE EXIT NOTCH. THERE WAS NO RUPTURE IN THE BALLOON AS REPORTED. THE TIP WAS CUT OFF AND THE SHAFT WAS CUT 4 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH, IN ORDER TO REMOVE THE OUTER MEMBER FROM THE INNER MEMBER TO CHECK ANY DAMAGES TO THE INNER MEMBER. IT WAS THEN OBSERVED THAT THERE WAS A TEAR IN THE INNER MEMBER 1 MM PROXIMAL TO THE DISTAL BALLOON MARKER, FOR A LENGTH OF 3 CM. THE MATERIAL AT THE TEAR WAS JAGGED. FACTORS THAT MAY CONTRIBUTE TO A TEAR IN THE INNER MEMBER INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, HANDLING OF THE PRODUCT DURING PREPARATION/USE, AND/OR INTERACTION WITH THE GUIDE WIRE. TO HELP ENSURE THAT THIS DAMAGE IS NOT THE RESULT OF MANUFACTURING, ALL PRODUCTS ARE VISUALLY INSPECTED FOR DAMAGE, INCLUDING AT THE POINT WHERE THE CATHETER IS INSERTED INTO THE PACKAGING COIL. ADDITIONALLY, ALL PRODUCTS ARE LEAK TESTED PRIOR TO PACKAGING AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY THE CATHETER BODY INTEGRITY PRIOR TO RELEASE. IN THIS CASE, IT IS LIKELY THAT THE INNER MEMBER WAS NOT DAMAGED PRIOR TO USE AS THERE WAS NO LEAK OR DAMAGE NOTED DURING PREPARATION OR THE INSPECTION PRIOR TO USE. IT IS POSSIBLE THAT THE GUIDE WIRE INTERACTED WITH THE INNER MEMBER, RESULTING IN THE NOTED TEAR IN THE INNER MEMBER. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR RUPTURES OR TEARS FOR THE SHAFT FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE NOTED TEAR IN THE INNER MEMBER COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VEIN GRAFT TO RIGHT CORONARY ARTERY STENTING PROCEDURE IN A HEAVILY CALCIFIED LESION AND MODERATELY TORTUOUS VESSEL, DURING PRE-DILATATION, THE RX TREK BALLOON WAS TAKEN TO 8 ATMOSPHERES AND LOST PRESSURE. A NON-ABBOTT BALLOON SUCCESSFULLY DILATED THE LESION AND THE PATIENT WAS STENTED WITHOUT ISSUE WITH VISION STENTS. THERE WAS NO ADVERSE PATIENT SEQUELA. ALTHOUGH REQUESTED, 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 0092963

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR