BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 4090598 · Received September 15, 2014

    Report

    Report Number
    2024168-2014-05931
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    April 5, 2013
    Report Date
    August 21, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DATE OF EVENT ESTIMATED. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE CORE WAS SEPARATED, AND THE PROXIMAL END OF THE BLACK POLYMER COATING WAS BUNCHED, TORN, PEELED, AND FOLDED DISTALLY OVER ITSELF. BASED ON A VISUAL AND DIMENSIONAL ANALYSIS INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE GUIDE WIRE WAS RETURNED IN THE RETURNED GOODS (RG) LAB WITH THE FOLLOWING DAMAGES NOTED: THE CORE IS SEPARATED, AND THE PROXIMAL END OF THE BLACK POLYMER COATING IS BUNCHED, TORN, PEELED, AND FOLDED DISTALLY OVER ITSELF. THERE WAS NO INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, IT WAS REPORTED THAT THE WHISPER GUIDE WIRE BECAME STUCK IN THE LEAD AND COULD NOT BE REMOVED. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED. ADDITIONAL INFORMATION RECEIVED FROM THE ACCOUNT CONFIRMED THAT THE GUIDE WIRE USED DURING THE PROCEDURE WAS A BOSTON SCIENTIFIC ACUITY WHISPER GUIDE WIRE, NOT AN ABBOTT VASCULAR WHISPER GUIDE WIRE. REPORTEDLY, THERE WERE NO ABBOTT VASCULAR DEVICES USED IN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569936 UNKNOWN GUIDE WIRES DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1