BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENKU DILATATION CATHETER

    MDR report key: 3830592 · Received May 23, 2014

    Report

    Report Number
    2024168-2014-03306
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE TENKU DILATION CATHETER DEVICE IS AN ABBOTT VASCULAR MANUFACTURED DEVICE WHICH IS DISTRIBUTED IN BY ST. JUDE MEDICAL (B)(4) COMPANY, LTD. THOUGH THIS DEVICE IS NOT COMMERCIALLY AVAILABLE FOR SALE IN THE US, IT IS SIMILAR TO A DEVICE CURRENTLY MARKETED FOR SALE IN THE US. THE PMA/510K # OF THIS MEDWATCH CORRESPOND TO THE DEVICE CURRENTLY MARKETED FOR SALE IN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION IN AN UNOPENED PACKAGE. THE REPORTED ISSUE WAS ABLE TO BE CONFIRMED. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD (ELHR) FOR THE REPORTED LOT REVEALED NO NONCONFORMING MATERIAL RECORDS (NCMRS), INDICATING ALL LOT RELEASE TESTING MET SPECIFICATIONS. A QUERY OF THE COMPLAINT-HANDLING DATABASE INDICATED THERE WERE NO SIMILAR INCIDENTS REPORTED FROM THIS LOT FOR THIS ISSUE. IN THIS CASE, THERE WERE NO UNTOWARD PATIENT EFFECTS SINCE THE DEVICE WAS NOT USED ON A PATIENT AND THE ISSUE WAS DETECTABLE PRIOR TO THE PROCEDURE. BASED ON THE INFORMATION REVIEWED FOR THIS LOT, IT WAS DETERMINED THAT THIS WAS AN ISOLATED INCIDENT AND NOT REPRESENTATIVE OF THE ENTIRE LOT. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED PER LOCAL QUALITY SYSTEM PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE UNPACKING AND PRIOR TO USE THE 1.2 X 6 MM TENKU RX BALLOON DILATATION CATHETER (BDC) HAD A FOREIGN MATERIAL OF ABOUT 2 MM SIZE IN THE PACKAGE. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308696 TENKU DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20808G1

    Patients

    Seq Age Sex Outcome Treatment
    1