BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2232087 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06112
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 8, 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
    PA, 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 NC TREK DILCATHER NOTED BLOOD VISIBLE ON THE OUTER MEMBER AND ON THE TIGHTLY FOLDED BALLOON, CONSISTENT WITH HANDLING. THE PROXIMAL HYPOTUBE SHAFT WAS SEPARATED 53 CM DISTAL TO THE STRAIN RELIEF TUBING, CONFIRMING THE REPORTED SEPARATION. THE FRACTURE FACES WERE OVAL SHAPED AS IF KINKED PRIOR TO SEPARATION. THERE WERE MULTIPLE BENDS NOTED TO 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 HYPOTUBE MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. IT IS LIKELY THAT THE HYPOTUBE WAS INADVERTENTLY HANDLED DURING PREPARATION RESULTING IN THE HYPOTUBE KINKING, AS THERE WAS NO DAMAGE TO THE CATHETER DURING REMOVAL FROM THE PACKAGING. FURTHER MANIPULATION WOULD HAVE CONTRIBUTED TO THE HYPOTUBE ULTIMATELY SEPARATING. A REVIEW OF THE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED NO OTHER INCIDENTS. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. TO HELP ENSURE THIS TYPE OF DAMAGE IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL PRODUCTS ARE VISUALLY INSPECTED FOR KINKS. ADDITIONALLY, A SAMPLING OF PRODUCT IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY.

    Description of Event or Problem · 1

    REPORTEDLY DURING PREP, THE NC TREK BALLOON CATHETER SEPARATED DISTALLY. THE DEVICE WAS NOT USED IN THE PATIENT. NO ADDITIONAL EVENT 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 1012661

    Patients

    Seq Age Sex Outcome Treatment
    1