BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE STEELCORE 18 GUIDE WIRE WITH MICROGLIDE COATING

    MDR report key: 2040408 · Received April 5, 2011

    Report

    Report Number
    2024168-2011-02397
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K980119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED GUIDE WIRE NOTED BLOOD ON THE TIP COILS, CONSISTENT WITH BEING ADVANCED INTO THE ANATOMY AS REPORTED. THERE WAS NO CONTRAST VISIBLE. THE TIP CORE WAS BENT IN A HOOK SHAPE AND THE COILS WERE PUSHED DISTAL FROM THE PROXIMAL SOLDER FOR A LENGTH OF 2.5 MM. THE COILS WERE PUSHED DISTAL FROM THE CENTER SOLDER FOR A LENGTH OF 4.5 MM, CONSISTENT WITH THE REPORTED INFORMATION. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. A LASER MICROMETER WAS USED TO MEASURE THE OUTER DIAMETER OF THE CORE UP TO THE COILS AND THIS MET THE MANUFACTURING CRITERIA. ADDITIONALLY, THE TIP WAS PULLED ON TO CONFIRM THAT THE TIP BALL AND CORE WERE STILL INTACT. BASED ON THE REPORTED INFORMATION AND ANALYSIS OF THE RETURNED GUIDE WIRE, THE STRETCHED TIP COILS ARE LIKELY THE RESULT OF THE TIP BEING TRAPPED WITHIN THE STENOSIS WHILE ATTEMPTING TO CROSS THE TOTAL OCCLUSION. WITH THE TIP IN A TRAPPED STATE, THE COILS LIKELY WERE STRETCHED DURING WITHDRAWAL OF THE WIRE, CAUSING THE REPORTED DIFFICULTY DURING REMOVAL. AS A RESULT OF THE DIFFICULTIES CROSSING FROM THE CROSSOVER APPROACH, THE PROCEDURE WAS CHANGED TO ENTERING THROUGH A POPLITEAL APPROACH WITH SUCCESS. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. OVERALL, THE REPORTED DIFFICULTY REMOVING AND STRETCHED TIP COILS APPEAR TO BE RELATED TO CASE CIRCUMSTANCES. THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. ALL GUIDE WIRE TIPS ARE INSPECTED AFTER THEY ARE LOADED INTO THE DISPENSER, AND MANUFACTURING PERFORMS 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 DURING A RECANALIZATION PROCEDURE OF A TOTALLY OCCLUDED LESION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY, USING A CROSSOVER APPROACH, THE STEELCORE GUIDE WIRE BECAME 'STUCK' IN THE STENOSIS. THIS OCCURRED AT THE BEGINNING OF THE PROCEDURE AND THE PHYSICIAN REMOVED THE GUIDE WIRE WITHOUT INCIDENT, HOWEVER IT BECAME UNRAVELED. ADDITIONALLY, THE PROCEDURE WAS CHANGED TO ENTERING THROUGH A POPLITEAL APPROACH WITH SUCCESS. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE STEELCORE 18 GUIDE WIRE WITH MICROGLIDE COATING GUIDE WIRE DQX AV-TEMECULA-CT 0080991

    Patients

    Seq Age Sex Outcome Treatment
    1