BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1980739 · Received February 7, 2011

    Report

    Report Number
    2024168-2011-00732
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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. STENT: XIENCE V 3.0 X 18 MM (PART#1009541-18/LOT#0072741/SERIAL#(B)(4)); XIENCE V 3.0 X 15 MM (PART#1009541-15/LOT#0083041/SERIAL#(B)(4)); MINI VISION 2.5 X 15 MM (PART#1007823-15/LOT#0042241) THE XIENCE V 3.0 X 18 MM (PART#1009541-18/LOT#0072741/SERIAL#(B)(4)), XIENCE V 3.0 X 15 MM (PART#1009541-15/LOT#0083041/SERIAL#(B)(4))AND MINI VISION 2.5 X 15 MM (PART#1007823-15/LOT#0042241) ARE BEING FILED UNDER SEPARATE MANUFACTURER REPORT NUMBERS. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). POSSIBLE CAUSES FOR DIFFICULTY IN REMOVING A DILATATION CATHETER AFTER INFLATION MAY INCLUDE: INTERACTION OF THE BALLOON WITH A STENT IMPLANT IF THE STENT IS NOT FULLY EXPANDED AND APPOSED TO THE VESSEL WALL, THE BALLOON NOT BEING FULLY DEFLATED PRIOR TO ATTEMPTING TO REMOVE THE BALLOON FROM THE IMPLANTED STENT, DAMAGE TO THE BALLOON, KINKS, BENDS, OBSTRUCTIONS IN THE GUIDING CATHETER LUMEN, OR DAMAGE TO THE GUIDING CATHETER. WITHOUT THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. THE PROFILE DIMENSIONS ON ALL BALLOON CATHETERS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 3.0 X 18 MM XIENCE, 3.0 X 15 MM XIENCE AND 2.5 X 15 MM MINI VISION FAILED TO CROSS A PREVIOUSLY IMPLANTED STENT (UNKNOWN TYPE) TO TREAT A LESION LOCATED IN THE PROXIMAL CIRCUMFLEX. A 5.0 X 12 MM VOYAGER NC WAS THEN UTILIZED FOR POST DILATATION OF THE PREVIOUSLY IMPLANTED STENT BECAUSE THERE WAS SOME CONCERN BY THE PHYSICIAN THAT THE THREE DEVICES WHICH FAILED TO CROSS MAY HAVE CAUSED SOME DAMAGE, ALTHOUGH NO DAMAGE WAS VISUALIZED ON ANGIO. THE POST-DILATATION OF THE EXISTING PREVIOUSLY PLACED STENT IN THE LEFT MAIN CORONARY ARTERY WAS DONE FOR PRECAUTIONARY REASONS. UPON WITHDRAWAL, THERE WAS SOME RESISTANCE NOTED BETWEEN THE BALLOON DILATATION CATHETER AND A NON-ABBOTT GUIDING CATHETER. THE EVENT CAUSED A DELAY IN THE PROCEDURE, HOWEVER, IT WAS NOT CONSIDERED A CLINICALLY SIGNIFICANT DELAY. NO PATIENT EFFECTS. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR