BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENKU DILATATION CATHETER

    MDR report key: 4122467 · Received September 26, 2014

    Report

    Report Number
    2024168-2014-06228
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT PRODUCT: GUIDE WIRE: RUNTHROUGH; GUIDE CATH: LAUNCHER EBU3.5. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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. TYPE PMA/510K # OF THIS MEDWATCH CORRESPOND TO THE DEVICE CURRENTLY MARKETED FOR SALE IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A RADIAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE 99% STENOSED, MILDLY TORTUOUS, HEAVILY CALCIFIED, DE NOVO, MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH A VESSEL DIAMETER OF 3.0 MM AND THE LESION LENGTH OF 30 MM RESISTANCE WAS MET DURING PROTECTIVE SHEATH REMOVAL AND THE 2.25 X 15 MM TENKU BALLOON DILATATION CATHETER (BDC) MET SLIGHT RESISTANCE IN THE ANATOMY BUT WAS USED FOR PRE-DILATATION WHEN DURING THE SECOND INFLATION AT 12 ATMOSPHERE (ATM) THE BALLOON RUPTURED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. A 2.0 X 14 MM UNSPECIFIED BDC WAS USED FOR PRE-DILATATION AND A 3.0 X 28 MM XIENCE STENT WAS DEPLOYED WITHOUT REPORTED ISSUE AND THE PROCEDURE WAS COMPLETED. 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
    601278 TENKU DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40604G1

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR