BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2003004 · Received February 28, 2011

    Report

    Report Number
    2024168-2011-01243
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 IN THE GUIDE WIRE LUMEN AND CRYSTALLIZED CONTRAST IN THE INFLATION LUMEN AND LOOSELY FOLDED BALLOON, CONSISTENT WITH PREPARATION USE OF THE PRODUCT IN THE PATIENT ANATOMY. THE OUTER MEMBER WAS STRETCHED 1 MM PROXIMAL TO THE PROXIMAL BALLOON SEAL FOR A LENGTH OF 1 MM. THE INNER MEMBER INSIDE OF THE BALLOON WAS BUNCHED 4 MM PROXIMAL TO THE DISTAL TAPER FOR A LENGTH OF 7 MM. THE TIP OF THE BALLOON WAS FLARED. PHYSICAL RESISTANCE WHEN ATTEMPTING TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT IS NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION AND ACCESSORY PRODUCT SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. THE 2/3 COLLAPSED BALLOON PROFILE COULD NOT BE MEASURED DUE TO THE DAMAGE NOTED TO THE INNER MEMBER. A NEW INDEFLATOR WAS USED TO PRESSURIZE THE BALLOON CATHETER AND THEN DEFLATE THE BALLOON. THE BALLOON DEFLATED FLAT. IT WAS REPORTED THE PATIENT ANATOMY WAS HEAVILY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE DIFFICULTIES POSITIONING THE CATHETER AND NOTED TIP DAMAGE. ADDITIONALLY, AS THE CATHETER MET RESISTANCE WITH THE CALCIFIED LESION, AS THE PHYSICIAN USED FORCE TO REMOVE THE CATHETER, THIS WOULD HAVE CONTRIBUTED TO THE SHAFT STRETCHING AND BUNCHING. IT WAS NOTED DURING THE RETURNED DEVICE FUNCTIONAL TESTING THAT THE BALLOON DEFLATED FLAT. IT IS POSSIBLE THAT A FLAT BALLOON COULD HAVE INTERACTED WITH THE LESION/ANATOMY AND CONTRIBUTED TO THE REPORTED DIFFICULTIES, BUT A FLAT BALLOON IS NOT UNCOMMON (ESPECIALLY WHEN DEFLATED OUTSIDE OF THE BODY) AND IT IS UNKNOWN IF THE BALLOON DEFLATED IN THE SAME MANNER DURING USE. 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. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE IN THE RIGHT CORONARY ARTERY WHICH WAS DESCRIBED AS HEAVILY CALCIFIED, THE TIP OF THE BALLOON CATHETER BECAME STUCK IN CALCIUM. THE PHYSICIAN PULLED REALLY HARD TO FREE THE TIP OF THE BALLOON CATHETER AND THE BALLOON CATHETER WAS ABLE TO BE REMOVED WITHOUT FURTHER INCIDENT. THIS EVENT DID NOT CAUSE A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER DILATATION CATHETER. THE PATIENT WAS FINE. NO ADDITIONAL EVENT OR PATIENT 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 0090961

    Patients

    Seq Age Sex Outcome Treatment
    1