BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE SUPRA CORE 35 GUIDE WIRE WITH MICROGLIDE COATING

    MDR report key: 2101037 · Received May 24, 2011

    Report

    Report Number
    2024168-2011-03657
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K083706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 OTHER SUPRACORE DEVICES ARE BEING SUBMITTED UNDER A SEPARATE MEDWATCH MFR#. EVALUATION SUMMARY: THE GUIDE WIRE WAS RETURNED WITH BLOOD ON THE COILS, CONSISTENT WITH HANDLING AND/OR INSERTION INTO THE GUIDING CATHETER. THERE WAS NO CONTRAST VISIBLE. THERE WAS NO DAMAGE OR IRREGULAR TEXTURE NOTED TO THE GUIDE WIRE. THE GUIDING CATHETER USED DURING THE PROCEDURE WAS NOT RETURNED. A LASER MICROMETER WAS USED TO MEASURE THE MAXIMUM OUTER DIAMETER OF THE GUIDE WIRE AND THIS MET MANUFACTURING CRITERIA. DURING FUNCTIONAL TESTING, THE GUIDE WIRE WAS ADVANCED THROUGH A 5FR INTRODUCER SHEATH WITH NO RESISTANCE NOTED. THE 5FR GUIDING CATHETER WAS NOT AVAILABLE FOR TESTING. THE GUIDE WIRE WAS ADVANCED THROUGH A NEW 6FR GUIDING CATHETER WITH NO RESISTANCE NOTED. POTENTIAL FACTORS WHICH COULD CAUSE RESISTANCE AND DIFFICULTY REMOVING THE GUIDE WIRE WITH A GUIDING CATHETER INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMY AND MORPHOLOGY, DAMAGE TO THE GUIDE WIRE, OBSTRUCTIONS TO THE INNER DIAMETER OF THE GUIDE CATHETER, KINKS OR BENDS IN THE GUIDING CATHETER, COAGULATION OF BLOOD OR CONTRAST IN THE GUIDING CATHETER AND/OR ON THE GUIDE WIRE. MANUFACTURING ANOMALIES COULD ALSO BE A POSSIBLE FACTOR; HOWEVER, MANUFACTURING PERFORMS 100% OUTER DIAMETER INSPECTION OF ALL GUIDE WIRES PRIOR TO PACKAGING. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUPRACORE GUIDE WIRE MET RESISTANCE DURING ADVANCEMENT AND REMOVAL THROUGH A 5 FR NON-ABBOTT GUIDING CATHETER ((B)(4)). REPORTEDLY, THE GUIDE WIRE "FELT ODD" AT THE DISTAL END OF THE WIRE AT THE WELD POINT. THERE WAS NO ADVERSE PATIENT EFFECT OR SIGNIFICANT DELAY IN PROCEDURE OR THERAPY. IT WAS ADDITIONALLY REPORTED THAT OTHER SUPRACORE GUIDE WIRES HAVE PREVIOUSLY MET RESISTANCE DURING ADVANCEMENT AND REMOVAL THROUGH 5 FR TAPERED TIP NON-ABBOTT GUIDING CATHETERS. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE SUPRA CORE 35 GUIDE WIRE WITH MICROGLIDE COATING GUIDE WIRE DQX AV-TEMECULA-CT 0120201

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR GUIDE CATH: 5 FR OMNIFLUSH (ANGIODYNAMICS)