BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3903458 · Received June 30, 2014

    Report

    Report Number
    2024168-2014-04245
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 5, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 RELEVANT INFORMATION. THE TREK AND BALANCE MIDDLEWEIGHT REFERENCED ARE BEING FILED UNDER SEPARATE MANUFACTURING REPORT NUMBERS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DIFFICULT TO POSITION AND REMOVE WITH THE GUIDE WIRE 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 THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY/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. ADDITIONALLY (B)(4) UNUSED DEVICES WERE RETURNED. THE (B)(4) DEVICES FROM (B)(4) UNIQUE LOTS WERE TESTED; ALL (B)(4) DEVICES PASSED THE VISUAL, DIMENSIONAL AND FUNCTIONAL TEST. BASED ON THE INFORMATION REVIEW, THE ANALYSIS OF THE RETURN, THE REVIEW OF THE MANUFACTURING RECORDS AND SIMILAR INCIDENT ANALYSIS, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ATTEMPTING TO PRELOAD THE TREK BALLOON DILATATION CATHETER (BDC) OVER THE BALANCE MIDDLEWEIGHT UNIVERSAL (BMWU) GUIDE WIRE RESISTANCE WAS MET AND THE BDC SEEMED TO DRAG DURING THE ADVANCEMENT ATTEMPT AND WHILE ATTEMPTING TO REMOVE THE BDC FROM THE GUIDE WIRE. IT WAS NOTED THAT A SECOND TREK BDC WAS ATTEMPTED AND MET THE SAME TYPE OF RESISTANCE. THERE WAS NO REPORTED PATIENT EFFECT. A THIRD UNSPECIFIED BDC WAS SUCCESSFULLY USED IN THE PROCEDURE WITHOUT THE NOTED ISSUE OF RESISTANCE. 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
    379371 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 31008G1

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR