BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2010634 · Received March 8, 2011

    Report

    Report Number
    2024168-2011-01511
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 TREK DILATATION CATHETER NOTED BLOOD VISIBLE ON THE HUB, SHAFT, BALLOON, AND IN THE GUIDE WIRE LUMEN. THERE WAS CONTRAST ON THE SHAFT AND IN THE INFLATION LUMEN AND LOOSELY FOLDED BALLOON. THIS IS CONSISTENT WITH PREPARATION AND USE OF THE PRODUCT IN THE PATIENT ANATOMY. THERE WERE MULTIPLE KINKS THROUGHOUT THE ENTIRE LENGTH OF THE HYPOTUBE. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE KINKS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. THE SIDEARM WAS LABELED AS A 2.50 X 20 LOT 0091661 CONSISTENT WITH THE REPORTED INFORMATION. THE PACKAGING MATERIALS WERE NOT RETURNED WITH THE DEVICE. A NEW INDEFLATOR FILLED WITH WATER WAS USED TO PRESSURIZE THE BALLOON TO NOMINAL PRESSURE OF 8 ATMOSPHERES (ATM). THE OUTER DIAMETER AND LENGTH OF THE BALLOON WERE MEASURED DID NOT MEET MANUFACTURING CRITERIA (UNDERSIZED). THE BALLOON MARKERS WERE ALIGNED WITH THE BALLOON SHOULDERS. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN DOES NOT FEEL THAT THE BALLOON LENGTH MEETS THE SPECS ON THE PACKAGING. IT IS HIS OPINION THAT THE BALLOON APPEARS SHORTER. THE DEVICE WAS USED FOR THE PROCEDURE AND IS RETURNING FOR ANALYSIS. NO PATIENT EFFECTS WERE REPORTED. 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 0091661

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR