BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE PROGRESS 120 GUIDE WIRE

    MDR report key: 3080328 · Received April 26, 2013

    Report

    Report Number
    2024168-2013-02603
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 4, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K091825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE IRREGULAR APPEARANCE WAS ABLE TO BE CONFIRMED. THE FAILURE TO ADVANCE AND DIFFICULT TO REMOVE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND DIMENSIONAL INSPECTION 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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE HEAVILY CALCIFIED, MID RIGHT CORONARY ARTERY. RESISTANCE WAS FELT DURING ADVANCEMENT OF THE GUIDE WIRE TO THE LESION. AFTER THE FAILED ATTEMPT TO CROSS, RESISTANCE WAS ALSO FELT DURING RETRACTION WHEN EXTRACTING THE GUIDE WIRE FROM THE GUIDING CATHETER; HOWEVER, AFTER BEING RETRACTED, THE DISTAL TIP OF THE GUIDE WIRE WAS OBSERVED TO BE DAMAGED, RESEMBLING A BALL OF WOOL. ANOTHER NON-ABBOTT GUIDE WIRE WAS USED IN AN ATTEMPT TO CROSS THE LESION; HOWEVER, AFTER MULTIPLE ATTEMPTS WAS UNSUCCESSFUL. NO FURTHER TREATMENT WAS ATTEMPTED. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181465 HI-TORQUE PROGRESS 120 GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2030901

    Patients

    Seq Age Sex Outcome Treatment
    1