BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TENKU DILATATION CATHETER

    MDR report key: 4998622 · Received August 12, 2015

    Report

    Report Number
    2024168-2015-04594
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 21, 2015
    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). EVALUATION SUMMARY: THE NC TENKU DILATION CATHETER DEVICE IS AN ABBOTT VASCULAR MANUFACTURED DEVICE WHICH IS DISTRIBUTED IN (B)(4) BY ST. JUDE MEDICAL (B)(4) COMPANY, LTD. ALTHOUGH THIS DEVICE IS NOT COMMERCIALLY AVAILABLE FOR SALE IN THE US, IT IS SIMILAR TO A DEVICE CURRENTLY MARKETED FOR SALE IN THE U.S. THE PMA/510K # OF THIS MEDWATCH CORRESPOND TO THE DEVICE CURRENTLY MARKETED FOR SALE IN THE US. (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DEFLATION DIFFICULTY WAS NOT CONFIRMED. THE REPORTED WRINKLED SHAFT WAS CONFIRMED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ECCENTRIC DE NOVO LESION WITH MILD TORTUOSITY AND MILD CALCIFICATION FROM THE PROXIMAL TO THE MID LEFT ANTERIOR DESCENDING ARTERY. PRE-DILATIONS OF THE LESION WERE PERFORMED USING AN UNSPECIFIED 2X10 MM BALLOON DILATATION CATHETER (BDC) AND A 2.5X15 MM BDC. AN UNSPECIFIED 2.5X23 MM STENT AND AN UNSPECIFIED 2.5X28 MM STENT WERE IMPLANTED IN THE TARGET LESION. A 2.5X12 MM NC TENKU RX BDC WAS INFLATED TO 12 ATMOSPHERES FOR 30 SECONDS FOR POST-DILATATION OF THE STENTS; HOWEVER, THE BALLOON COULD NOT BE DEFLATED. THE INFLATION DEVICE WAS REMOVED AND REPLACED WITH A NEW INFLATION DEVICE BUT THE BALLOON WOULD NOT DEFLATE. A GUIDE WIRE USED TO PROTECT A SIDE BRANCH WAS REMOVED. THE BALLOON WAS PARTIALLY DEFLATED. FINALLY THE BALLOON WAS COMPLETELY DEFLATED AND REMOVED FROM THE PATIENT ANATOMY. UPON REMOVAL IT WAS NOTED THAT THE OUTER MEMBER PROXIMAL TO THE GUIDE WIRE EXIT NOTCH WAS WRINKLED. A NON-ABBOTT BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO RESISTANCE DURING REMOVAL OF THE STYLET OR PROTECTIVE SHEATH. THE DEVICE WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO REPORTED ADVERSE EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529582 NC TENKU DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 41112G1

    Patients

    Seq Age Sex Outcome Treatment
    1