BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2030015 · Received March 25, 2011

    Report

    Report Number
    2024168-2011-02060
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: EVALUATION OF THE RETURNED MINI TREK CATHETER NOTED BLOOD VISIBLE ON THE TIGHTLY FOLDED BALLOON AND CONTRAST IN THE INFLATION LUMEN, CONSISTENT WITH HANDLING AND PREPARATION. THE HYPOTUBE HAD SEPARATED AT THE DISTAL END OF THE HUB INSIDE OF THE STRAIN RELIEF TUBING. THE FRACTURE FACES WERE OVAL AS IF KINKED PRIOR TO SEPARATION. THERE WAS AN ADDITIONAL KINK NOTED IN THE DISTAL SHAFT AND MULTIPLE BENDS THROUGHOUT THE HYPOTUBE. THIS TYPE OF FAILURE IS OFTEN ATTRIBUTED TO DUCTILE OVERLOAD AT A BEND. KINKS OR BENDS IN THE SHAFT CAN LEAD TO WEAKENING OF THE CATHETER MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. IT IS POSSIBLE THE HUB AND HYPOTUBE WERE DAMAGED DURING REMOVAL FROM THE COIL DISPENSER OR DURING PREPARATION FOR USE RESULTING IN THE HYPOTUBE KINKING AND ULTIMATELY SEPARATING. 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. 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. DUE TO THE LOCATION OF THE HYPOTUBE SEPARATION, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED AND MANUFACTURING WILL BE NOTIFIED TO FURTHER INVESTIGATE. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED FOR KINKS DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE BALLOON CATHETER WAS REMOVED FROM THE PACKAGE, THE PROXIMAL SHAFT SEPARATED AT THE HUB. THE DEVICE WAS NOT USED ON THE PATIENT. 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 1010562

    Patients

    Seq Age Sex Outcome Treatment
    1