BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2200424 · Received August 11, 2011

    Report

    Report Number
    2024168-2011-05669
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE CATHETER NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND ON THE HUB, CONSISTENT WITH HANDLING AND THE CATHETER ADVANCED OVER A GUIDE WIRE. THE BALLOON WAS TIGHTLY FOLDED. THE HYPOTUBE WAS SEPARATED AT THE DISTAL END OF THE HUB, CONFIRMING THE REPORTED SEPARATION. THE FRACTURE FACE WAS OVAL SHAPED AS IF KINKED PRIOR TO SEPARATION. THIS TYPE OF FAILURE IS OFTEN ATTRIBUTED TO DUCTILE OVERLOAD AT A BEND. KINKS OR BENDS IN THE HYPOTUBE CAN LEAD TO WEAKENING OF THE HYPOTUBE 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 100% VISUALLY INSPECTED FOR KINKS. ADDITIONALLY, A SAMPLING OF PRODUCT IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY. IT IS LIKELY THAT THE HYPTOUBE WAS INADVERTENTLY HANDLED RESULTING IN THE SEPARATION. A SEARCH OF THE LOT HISTORY RECORD INDICATED NO NON-CONFORMING MATERIAL RECORDS FOR THE LOT RELATED TO THE INCIDENT. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE INDICATED NO OTHER INCIDENTS, THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. BASED ON THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING OF THE MINI TREK FROM THE PACKAGING HOOP, THE PROXIMAL AREA NEAR THE HUB OF THE CATHETER SEPARATED. THE CATHETER WAS REPLACED WITH ANOTHER DEVICE TO CONTINUE WITH THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. 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 0070262

    Patients

    Seq Age Sex Outcome Treatment
    1