BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK II OTW CORONARY DILATATION CATHETER

    MDR report key: 3903415 · Received June 30, 2014

    Report

    Report Number
    2024168-2014-04237
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 10, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: HT FLOPPY; GUIDE CATH: Q4 BOSTON RUNWAY GUIDE. IT WAS REPORTED THAT DURING ADVANCEMENT AND RETRACTION OF THE UNKNOWN OTW MINI TREK II BALLOON CATHETER OVER THE HT FLOPPY GUIDE WIRE, DRAGGING AND STICKING WAS FELT. 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 FINISHED PRODUCT LOT HISTORY RECORD FOR THIS LOT REVEALED NO NONCONFORMING MATERIAL RECORDS. A QUERY OF THE COMPLAINT HANDLING DATABASE 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 DURING ADVANCEMENT AND RETRACTION OF THE 2.0X15 MM OTW MINI TREK II BALLOON CATHETER OVER THE HT FLOPPY GUIDE WIRE, DRAGGING AND STICKING WAS FELT. THE BALLOON WAS USED SUCCESSFULLY FOR PREDILATATION. THE STENT DELIVERY SYSTEM (SDS) WAS ABLE TO ADVANCE, THE STENT DEPLOYED AND THE SDS RETRACTED WITHOUT ISSUE WITH THE SAME GUIDE WIRE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379886 MINI TREK II OTW CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 31018G1

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR CONCOMITANT MEDICAL DEVICES