BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2111516 · Received June 2, 2011

    Report

    Report Number
    2024168-2011-03833
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE ON THE TIGHTLY FOLDED BALLOON AND CONTRAST IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION AND THE CATHETER ADVANCED INTO THE PATIENT ANATOMY. THE DISTAL EDGE OF THE SOFT TIP WAS JAGGED. THERE WAS A KINK IN THE INNER MEMBER AND PROXIMAL BALLOON TAPER 3 MM DISTAL TO THE PROXIMAL BALLOON SEAL. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE KINKS AND TIP DAMAGE MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THE REPORTED DIFFICULTIES WERE UNABLE TO BE CONFIRMED AS A NEW INDEFLATOR FILLED WITH GASTROGRAFIN, DILUTED 1:1 WITH WATER WAS USED TO PRESSURIZE THE BALLOON CATHETER TO THE RATED BURST PRESSURE (RBP). THE INFLATION TIMES WERE MEASURED AND MET MANUFACTURING CRITERIA. EACH TIME THE BALLOON WAS ABLE TO HOLD PRESSURE. IT IS POSSIBLE THERE WAS A FAULTY CONNECTION BETWEEN THE CATHETER AND THE INFLATION DEVICE; HOWEVER THIS COULD NOT BE CONFIRMED. DURING FUNCTIONAL TESTING, THE INNER MEMBER COLLAPSED FOR A LENGTH OF 24.5 CM FROM THE TIP. A GUIDE WIRE WAS NOT INSERTED INTO THE GUIDE WIRE LUMEN DURING INFLATION, WHICH LIKELY CONTRIBUTED TO THE INNER MEMBER COLLAPSING AS THE LUMEN LACKED SUPPORT DURING PRESSURIZATION. 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 COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, THE REPORTED DIFFICULTIES WERE UNABLE TO BE CONFIRMED AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 2.0 X 20 MM MINI TREK WOULD NOT INFLATE TO TREAT A LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. ANOTHER MINI TREK (2.5 X 20 MM) WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0100161

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR