BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    014 HT WINN GUIDE WIRE

    MDR report key: 2020748 · Received March 16, 2011

    Report

    Report Number
    2024168-2011-01771
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. IN THIS CASE, THE PATIENTS ANATOMICAL INFORMATION WAS NOT PROVIDED; HOWEVER, IT MAY BE POSSIBLE THAT THE DIFFICULTY CROSSING WAS RELATED TO ANATOMICAL CONDITIONS. FACTORS THAT CAN CONTRIBUTE TO RESISTANCE WITH A SUPPORT CATHETER MAY INCLUDE, BUT ARE NOT LIMITED TO, ANATOMICAL CONDITIONS, DEVICE PLACEMENT TECHNIQUE, CATHETER SUPPORT, INNER DIAMETER OF THE CATHETER, OUTER DIAMETER OF THE GUIDE WIRE, CONDITION OF THE GUIDE WIRE/CATHETER, BLOOD AND/OR CONTRAST BUILD UP, OR DAMAGE TO THE CATHETER. TO HELP ENSURE THIS IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL GUIDE WIRES ARE VISUALLY INSPECTED FOR DAMAGE AND PROPER GUIDE WIRE MOVEMENT ON THE MANUFACTURING LINE. IT APPEARS THAT THE REPORTED RESISTANCE CONTRIBUTED TO THE ACCORDION AND PEELING OF THE GUIDE WIRE COATING. BECAUSE THIS DAMAGE WAS NOT NOTED PRIOR TO USE, IT IS LIKELY THAT THE DAMAGE OCCURRED DURING ADVANCEMENT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORT AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED. WITHOUT HAVING THE GUIDE WIRE TO EXAMINE, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY COULD NOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. MANUFACTURING PERFORMS 100% OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON PERFORMING AN ANTERIOR TIBIAL CASE WITH THE GUIDE WIRE, RESISTANCE WAS MET WITH THE NON-ABBOTT SUPPORT CATHETER AND ALSO, THE DEVICES WOULD NOT CROSS THE LESION SITE. BOTH THE SUPPORT CATHETER AND THE GUIDE WIRE WERE REMOVED FROM THE PATIENT AS A UNIT. AFTER REMOVAL THE GUIDE WIRE COATING WAS PEELING AND WAS ACCORDIONED. IT WAS CONFIRMED THAT NOTHING CAME OFF IN THE PATIENT. A NON-ABBOTT GUIDE WIRE WAS USED AND THE PATIENT WAS TREATED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 014 HT WINN GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 0080401

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR COOK CATHETER