BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2071087 · Received April 27, 2011

    Report

    Report Number
    2024168-2011-02957
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING, LESION CALCIFICATION AND TORTUOSITY, AN INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTIONS WITH OTHER DEVICES. RETURN OF THE MINI TREK CATHETER MAY HAVE FURTHER AIDED THE INVESTIGATION; HOWEVER, SINCE IT WAS REPORTED THAT NO LEAKS WERE NOTED DURING PREPARATION FOR USE AND THE CATHETER WAS INITIALLY PRESSURIZED ONCE WITHOUT INCIDENT, THIS INDICATES THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. THE LESION WAS ALSO REPORTED AS MILDLY TORTUOUS, MILDLY CALCIFIED AND 99% STENOSED, WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTY. THE BALLOON MATERIAL LIKELY BECAME DAMAGED (SCRATCHED) FROM INTERACTIONS WITH OTHER DEVICES AND/OR THE TORTUOUS AND CALCIFIED LESION, SUCH THAT THE BALLOON RUPTURED UPON A THIRD INFLATION ATTEMPT. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FOR A BALLOON RUPTURE FROM THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT, THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE DEVICE AND NOT A PRODUCT QUALITY DEFICIENCY. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY RBP AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS IN THE RIGHT CORONARY ARTERY (RCA), WITH A VESSEL DIAMETER OF 2.5 MM, AND A LESION LENGTH OF 25 MM. THE LESION WAS MILDLY TORTUOUS AND MILDLY CALCIFIED WITH A 99% STENOSIS. PREDILATATION WAS PERFORMED AT THE LESION WITH THE 2.0 X 12 MM TREK, AND WAS THEN ADVANCED FORWARD. THE BALLOON RUPTURED AT 10 ATMOSPHERES (ATM) ON THE THIRD INFLATION. A NON-ABBOTT BALLOON WAS USED FOR PREDILATATION, A XIENCE V WAS DEPLOYED AND THEN PREDILATATION WAS PERFORMED WITH THE STENT DELIVERY SYSTEM BALLOON TO COMPLETE THE PROCEDURE. NO PATIENT EFFECTS WERE 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 1011862

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: SION