BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2874479 · Received December 14, 2012

    Report

    Report Number
    2024168-2012-07977
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 19, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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. CONCOMITANT MEDICAL DEVICES: GUIDE WIRE: ASAHI PROWATER 180 CM; HI-TORQUE WHISPER 190 CM. (B)(4) - IMPROPER OR INCORRECT PROCEDURE OR METHOD: INCORRECT PREP. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE RESISTANCE WITH THE CATHETER WAS NOT CONFIRMED. BASED ON VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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. IT SHOULD BE NOTED THAT INSTRUCTION FOR USE (IFU) MINI TREK/TREK OTW INSTRUCTS: SUBMERGE THE BALLOON IN STERILE HEPARINIZED NORMAL SALINE DURING BALLOON PREPARATION TO ACTIVATE THE COATING. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE ADDITIONAL HI-TORQUE WHISPER AND ASAHI PROWATER DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORT THAT DURING A PROCEDURE OF THE MODERATELY TORTUOUS, FIRST OBTUSE MARGINAL OF THE CIRCUMFLEX ARTERY, THE ASAHI PROWATER GUIDE WIRE WAS POSITIONED AND THE 2.0 X 12 MM MINI TREK OTW BALLOON DILATATION CATHETER (BDC) MET RESISTANCE DURING ADVANCING AND REMOVAL BUT THE BDC WAS INFLATED AND DEFLATED THREE TIMES AT 8 ATMOSPHERE (ATM) WITHOUT ISSUE. THE BDC WAS LEFT IN POSITION AND THE PROWATER WAS REMOVED AND A WHISPER GUIDE WIRE WAS ADVANCED AND POSITIONED. IT WAS NOTED THAT ALTHOUGH IMPROVED, THERE WAS STILL RESISTANCE NOTED WITH THE MINI TREK OTW BDC. THE PROCEDURE WAS COMPLETED AND THE BDC AND GUIDE WIRE WERE REMOVED AS A SYSTEM FROM THE ANATOMY WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20914G1

    Patients

    Seq Age Sex Outcome Treatment
    1