BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TENKU DILATATION CATHETER

    MDR report key: 2933429 · Received January 29, 2013

    Report

    Report Number
    2024168-2013-00453
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    December 29, 2012
    Report Date
    January 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    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. THE TENKU BALLOON DILATION CATHETER DEVICE IS AN ABBOTT VASCULAR MANUFACTURED DEVICE WHICH IS DISTRIBUTED IN (B)(4). 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. SUSPECT MEDICAL DEVICE INFO AND G5/PMA/510K # OF THIS MEDWATCH CORRESPOND TO THE DEVICE CURRENTLY MARKETED FOR SALE IN THE US. 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. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH MILD TORTUOSITY AND HEAVY CALCIFICATION. THE 2.75 X 15 MM TENKU BALLOON CATHETER WAS ADVANCED WITHOUT ISSUE AND INFLATED TO 14 ATMOSPHERES (ATM) FOR PRE-DILATATION. DURING THE SECOND INFLATION OF 18 ATMOSPHERES (ATM), A BALLOON RUPTURE OCCURRED. THERE WAS NO RESISTANCE NOTED DURING REMOVAL OF THE DEVICE. A NON-ABBOTT STENT WAS IMPLANTED AND POST-DILATATION WAS PERFORMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PHYSICIAN COMMENTED THAT THE BALLOON RUPTURE MAY BE DUE TO THE CALCIFICATION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39216 NC TENKU DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2100261

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: RUNTHROUGHGUIDE CATH: PROFIT JL35