BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2927167 · Received January 23, 2013

    Report

    Report Number
    2024168-2013-00372
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    February 23, 2012
    Report Date
    December 31, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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. 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 LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THE LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY. THE SECOND MINI TREK REFERENCED BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE FEMORAL ARTERY. TWO 2.0 X 15 MM MINI TREK BALLOON CATHETERS WERE PREPARED PER THE INSTRUCTIONS FOR USE, PRIOR TO USE. THE FIRST 2.0 X 15 BALLOON CATHETER (LOT # 2012761) WAS ADVANCED WITHOUT ISSUE AND INFLATED TO AN UNKNOWN PRESSURE; HOWEVER, THE BALLOON RUPTURED. THE SECOND 2.0 X 15 MM BALLOON CATHETER (LOT # 1121361) WAS ADVANCED WITHOUT ISSUE AND INFLATED TO AN UNKNOWN PRESSURE. DURING THE SECOND INFLATION OF 12 ATMOSPHERES (ATM), THE BALLOON RUPTURED. BOTH BALLOON CATHETERS WERE REMOVED WITHOUT RESISTANCE. A NEW MINI TREK WAS USED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32740 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2012761

    Patients

    Seq Age Sex Outcome Treatment
    1