BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 3790062 · Received May 5, 2014

    Report

    Report Number
    2024168-2014-02803
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 16, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY TO REMOVE COULD NOT BE DETERMINED, THE ADDITIONAL THERAPY/ NON-SURGICAL TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR DIFFICULTY TO REMOVE REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY, TWO NON-ABBOTT GUIDE WIRES WERE ADVANCED. A 1.2X12 OVER THE WIRE (OTW) MINI TREK DILATATION CATHETER WAS ADVANCED AND DILATATION WAS SUCCESSFULLY PERFORMED WITHOUT ISSUE. AFTER DEFLATION OF THE BALLOON, THE PHYSICIAN WANTED TO REMOVE THE DILATATION CATHETER AND USED A SYRINGE INJECTION WITH NACL; HOWEVER, THE BALLOON COULD NOT BE WITHDRAWN OFF OF THE GUIDE WIRES AND WAS STUCK ON THE GUIDE WIRES. AN EXTENSION GUIDE WIRE WAS USED TO EXTEND THE GUIDE WIRE AND REMOVE THE 1.2X12 OTW MINI TREK DILATATION CATHETER AND THE TWO NON-ABBOTT GUIDE WIRES. THE TWO NON-ABBOTT GUIDE WIRES WERE THEN USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. AN UNSPECIFIED STENT WAS IMPLANTED TO TREAT THE TARGET LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269417 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 108156Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE WIRE: FIELDER FC, TERUMO RUNTHROUGH NS