BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2230127 · Received August 31, 2011

    Report

    Report Number
    2024168-2011-06058
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: PILOT. INFLATION: BSX. GUIDE CATH: MEDTRONIC. SHEATH: TERUMO. STENT: XIENCE PRIME 3.0 X 12. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURES INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, WEAK MATERIALS, EXCESSIVELY APPLIED PRESSURE, OR INTERACTIONS WITH ACCESSORY DEVICES, PATIENT ANATOMY, AND/OR LESION CALCIFICATION OR TORTUOSITY. RETURN OF THE NC TREK CATHETER USED IN THE PROCEDURE MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. THERE WAS NO REPORT OF ANY LEAK IN THE CATHETER NOTED DURING PREPARATION FOR USE, WHICH WOULD SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE. IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH ACCESSORY DEVICES, THE MILDLY CALCIFIED LESION, OR THE IMPLANTED STENT SUCH THAT THE BALLOON RUPTURED UPON THE FIRST INFLATION AT 6 ATMOSPHERES, WHICH IS BELOW THE RATED BURST PRESSURE (RBP). TO ENSURE THIS IS NOT A RESULT OF MANUFACTURING, ALL BALLOON CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RBP. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS IN THE MID CORONARY WITH MILD TORTUOSITY AND MILD CALCIFICATION. A 3.0 X 12 MM XIENCE PRIME STENT WAS IMPLANTED IN THE TARGET LESION. THE NC TREK 3.0 X 15 MM WAS USED FOR POST-DILATATION. DURING INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. NO RESISTANCE WAS FELT DURING ADVANCEMENT OR RETRACTION. THE BALLOON WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE. A NEW TREK BALLOON (SAME SIZE) WAS USED FOR POST-DILATATION WITH A GOOD RESULT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1011261

    Patients

    Seq Age Sex Outcome Treatment
    1