BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 1981743 · Received February 8, 2011

    Report

    Report Number
    2024168-2011-00756
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CATHETER WAS INADVERTENTLY HANDLED DURING REMOVAL FROM THE DISPENSER COIL, RESULTING IN THE SHAFT KINKING. FURTHER MANIPULATION LIKELY CONTRIBUTED TO THE SHAFT ULTIMATELY SEPARATING; HOWEVER THIS COULD NOT BE CONFIRMED. 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. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, WITH THE LIMITED INFORMATION PROVIDED AND WITHOUT THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE FOR THE REPORTED HYPOTUBE SEPARATION COULD NOT BE CONFIRMED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE UNPACKAGING THE RX TREK PROXIMAL SHAFT WAS FOUND KINKED AND HAD SEPARATED. THERE WAS NO PATIENT INVOLVEMENT. 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 0061561

    Patients

    Seq Age Sex Outcome Treatment
    1