BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE STEELCORE 18 GUIDE WIRE WITH MICROGLIDE COATING

    MDR report key: 2090413 · Received May 16, 2011

    Report

    Report Number
    2024168-2011-03511
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K980119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INITIALLY REPORTED THAT THE DEVICE WAS EXPECTED TO BE RETURNED. THE DEVICE HAS NOT BEEN RECEIVED. IF THE DEVICE IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. BASED ON THE REPORTED INFORMATION, THE SECOND LESION WAS DESCRIBED AS HEAVILY CALCIFIED PREVENTING THE WIRE FROM CROSSING. A SEPARATION OF THE GUIDE WIRE MAY HAPPEN WHEN THE CORE IS SUBJECTED TO TENSILE OR TORSIONAL LOADS BEYOND THE DESIGN LIMITS CAUSING THE CORE TO STRETCH AND/OR SEPARATE AS REPORTED. A GUIDE WIRE BEING OVER PULLED OR OVER TORQUED WOULD REQUIRE THE TIP TO BE TRAPPED. BASED ON THE REPORTED INFORMATION, IT APPEARS THAT WHILE ATTEMPTING TO CROSS THE HEAVILY CALCIFIED LESION, TORQUING AND MANEUVERING CAUSED THE TIP TO BECOME LODGED WITHIN THE LESION LEADING TO DIFFICULTY REMOVING AND ULTIMATELY CAUSING THE TIP TO LOSE ITS SHAPE AND SEPARATE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT AND THERE IS NO INDICATION OF A LOT SPECIFIC DEFICIENCY. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS FOR FAILURE TO ADVANCE OR DIFFICULT TO REMOVE REPORTED FOR THIS LOT. IT APPEARS THAT THE REPORTED DIFFICULTIES ARE RELATED TO CASE CIRCUMSTANCES AND THERE IS NO INDICATION TO SUGGEST A PRODUCT DEFICIENCY. ALL GUIDE WIRE TIPS ARE INSPECTED AFTER BEING LOADED INTO THE DISPENSER, AND AN OUTER DIAMETER INSPECTION OF ALL DEVICES IS PERFORMED PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY.

    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 RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED GUIDE WIRE NOTED BLOOD AND CONTRAST ON THE COILS, CONSISTENT WITH USE. THERE WERE THREE BENDS IN THE CORE 5 MM, 7 MM AND 1 CM PROXIMAL TO THE TIPBALL. THE TIPBALL, CENTER SOLDER AND PROXIMAL SOLDER WERE ALL CORRODED. THIS CORROSION LIKELY OCCURRED DURING TRANSIT OF THE PRODUCT BACK TO ABBOTT VASCULAR, AND DOES NOT APPEAR TO BE RELATED TO THE REPORTED COMPLAINT. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. THERE WERE STRETCHED TIP COILS DISTAL TO THE TIPBALL. THE CORE WAS NOT SEPARATED AS REPORTED. THE OUTER DIAMETER OF THE GUIDE WIRE WAS MEASURED AND MET MANUFACTURING CRITERIA. THE TIP WAS TUGGED ON TO CONFIRM THAT THE CORE WAS INTACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT TWO LOWER EXTREMITY LESIONS, ONE AT THE BEGINNING OF THE POSTERIOR TIBIAL ARTERY (PTA) WHICH WAS MILDLY CALCIFIED AND THE OTHER AT THE EXTREME END OF THE SAME WHICH WAS HEAVILY CALCIFIED THE STEELCORE GUIDE WIRE CROSSED THE INITIAL LESION EASILY BUT COULD NOT PASS THROUGH THE SECOND LESION. THE DOCTOR TRIED DEVICE MANEUVERING AFTER WHICH THE GUIDE WIRE BECAME CAUGHT IN THE LESION AND WHEN ATTEMPTING TO PULL THE GUIDE WIRE OUT IT STARTED SEPARATING AND LOST THE ORIGINAL SHAPE. THE DEVICE WAS REMOVED FROM THE ANATOMY. A NON-ABBOTT GUIDE WIRE AND A FOX SV BALLOON WERE USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED AS DOING FINE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THOUGH REQUESTED, 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 9051991

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR SHEATH: 5F