BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE STEELCORE 18 LT GUIDE WIRE WITH MICROGLIDE COATING

    MDR report key: 11599679 · Received March 31, 2021

    Report

    Report Number
    2024168-2021-02582
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    March 10, 2021
    Report Date
    May 3, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    UDI-DI
    08717648049347
    PMA / PMN Number
    K982876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DIFFICULTY TO REMOVE WAS NOT TESTED BASED ON DEVICE CONDITION. THERE WERE ADDITIONAL NOTED DAMAGES TO THE CORE AND THE COILS. ALSO, A NOTED CORKSCREW BEND ON THE CORE OF THE WIRE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. IT MAY BE POSSIBLE THAT ANATOMICAL CONDITIONS (HEAVILY CALCIFIED LESION) AND THE PREVIOUSLY IMPLANTED STENT CONTRIBUTED TO A REDUCED CLEARANCE CAUSING THE RESISTANCE BETWEEN THE SECOND SUPERA DELIVERY SYSTEM AND THE STEELCORE GUIDE WIRE; HOWEVER, THIS COULD NOT BE CONFIRMED. THE ADDITIONAL DAMAGES TO THE CORE AND THE COILS ARE LIKELY CONTRIBUTED TO CASE CIRCUMSTANCES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE SUPERA STENT DELIVERY SYSTEM, REFERENCED IS FILED UNDER SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE LEFT SUPERFICIAL FEMORAL ARTERY, HEAVILY CALCIFIED LESION. A SUPERA STENT WAS SUCCESSFULLY IMPLANTED. A SECOND SUPERA STENT (S-60-040-120-P6, 0050461) WAS ALSO DEPLOYED SUCCESSFULLY. WHILE REMOVING THE SECOND SUPERA DELIVERY SYSTEM HOWEVER, RESISTANCE WAS MET BETWEEN THE SECOND SUPERA DELIVERY SYSTEM AND THE STEELCORE GUIDE WIRE (1007710-J, 0080761). THE GUIDE WIRE AND SUPERA DELIVERY SYSTEM WERE REMOVED WITHOUT FURTHER ISSUES AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT, NO INTERVENTION OR TREATMENT REQUIRED, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497866 HI-TORQUE STEELCORE 18 LT GUIDE WIRE WITH MICROGLIDE COATING PERIPHERAL VASCULAR GUIDEWIRE DQX ABBOTT VASCULAR 1007710-J 0080761 08717648049347

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 1 IMPLANTED SUPERA STENT| 6 FRENCH SHEATH| SUPERA STENT DELIVERY SYSTEM