BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENKU DILATATION CATHETER

    MDR report key: 4813757 · Received June 2, 2015

    Report

    Report Number
    2024168-2015-03140
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    May 14, 2015
    Report Date
    May 14, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SEPARATION WAS CONFIRMED. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. 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 QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: DIL CATH: THREADER MICRO-DILATATION CATHETER 1.2X12MM; GUIDE WIRE: SION BLACK, SION BLUE; GUIDE CATH: HEARTRAIL AL1. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE TENKU BALLOON DILATATION CATHETER IS AN ABBOTT VASCULAR MANUFACTURED DEVICE WHICH IS DISTRIBUTED IN (B)(4) 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 U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY CALCIFIED, CONCENTRIC, 100% STENOSED, CHRONIC TOTALLY OCCLUDED, DISTAL, LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH A VESSEL DIAMETER OF 3.0 MM AND LESION LENGTH OF 15 MM, AN ANCHOR BALLOON TECHNIQUE WAS PERFORMED USING A 3.0 X 12 MM RX TENKU BALLOON DILATATION CATHETER (BDC) WHICH BECAME SEPARATED AT THE SHAFT WHEN A NON-ABBOTT BDC WAS BEING ADVANCED TO THE MID LAD AND THE RX TENKU WAS BEING REMOVED. THE DISTAL FRAGMENT OF THE SHAFT WAS RETRIEVED FROM THE ANATOMY USING A GOOSENECK SNARE DEVICE. THE PROCEDURE WAS STOPPED AND FUTURE TREATMENT IS BEING CONSIDERED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354393 TENKU DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40401G1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CONCOMITANT MEDICAL DEVICES