BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2930044 · Received January 25, 2013

    Report

    Report Number
    2024168-2013-00399
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 2, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SEPARATION WAS ABLE TO BE CONFIRMED; HOWEVER THE MISSING COATING WAS UNABLE TO BE CONFIRMED. THE DIFFICULTIES REMOVING THE SDS COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT DUE TO THE SEPARATION. BASED ON A VISUAL AND DIMENSIONAL INSPECTION AND SCANNING ELECTRON MICROSCOPY (SEM) IMAGING AND CHEMICAL (CHEM) 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 THE REPORTED EVENT. 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 REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE HAS BEEN RETURNED FOR INVESTIGATION. THE INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY PROCEDURE, THE BALANCE MIDDLEWEIGHT UNIVERSAL II(BMWUII) GUIDE WIRE WAS ATTEMPTED TO BE USED BUT THE HYDROPHILIC COATING WAS MISSING IN SPOTS MAKING DEVICES DIFFICULT TO ADVANCE AND THE DEVICES BECAME STUCK. DURING THE ATTEMPT TO REMOVED THE UNSPECIFIED STENT DELIVERY SYSTEM (SDS) THE GUIDE WIRE WAS ALSO REMOVED FROM THE ANATOMY. OUTSIDE THE ANATOMY, IT WAS NOTED THAT THE BMW WAS BROKEN NEAR THE HYPOTUBE SHAFT AREA. 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
    35315 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2110871

    Patients

    Seq Age Sex Outcome Treatment
    1