BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2061133 · Received April 18, 2011

    Report

    Report Number
    2024168-2011-02691
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. ANALYSIS OF THE RETURNED PRODUCT NOTED NO BLOOD OR CONTRAST VISIBLE AND THE BALLOON WAS TIGHTLY FOLDED, CONSISTENT WITH THE REPORTED INFORMATION THE CATHETER WAS NOT USED IN THE PATIENT. THE HYPOTUBE AND STRAIN RELIEF TUBING WERE SEPARATED AT THE DISTAL END OF THE NOSE PIECE, CONFIRMING THE REPORTED INFORMATION. THE HYPOTUBE FRACTURE FACE WAS OVAL SHAPED AS IF KINKED PRIOR TO SEPARATION. THE STRAIN RELIEF MATERIAL WAS STRETCHED AND JAGGED AT THE SEPARATION. 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. 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. IN THIS CASE, IT IS LIKELY THAT THE HUB AND SHAFT WERE INADVERTENTLY HANDLED DURING REMOVAL FROM THE PACKAGING, RESULTING IN THE SHAFT KINKING. FURTHER MANIPULATION WOULD HAVE CONTRIBUTED TO THE SHAFT 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. IN THIS CASE, THE REPORTED HYPOTUBE SEPARATION APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RX TREK HUB SEPARATED FROM THE SHAFT WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0092261

    Patients

    Seq Age Sex Outcome Treatment
    1