BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2820499 · Received November 6, 2012

    Report

    Report Number
    2024168-2012-06974
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 12, 2012
    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). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE HT PILOT GUIDE WIRE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED DIFFICULTY WAS CONFIRMED. BASED ON VISUAL 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. 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 OF THE TREK BALLOON OVER A PILOT GUIDE WIRE, WHILE STILL OUTSIDE THE PATIENT ANATOMY, RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. RESISTANCE WAS ALSO ENCOUNTERED DURING THE ATTEMPT TO RETRACT THE BALLOON AND THE DEVICES BECAME STUCK TOGETHER. THE SHAFT OF THE TREK BALLOON BECAME BUNCHED/ACCORDIONED DURING THE ATTEMPT TO RETRACT IT FROM THE GUIDE WIRE. BOTH DEVICES WERE RETRACTED AS A UNIT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20426G1

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: HT PILOT