BEUDAMED
    FDA Adverse Event Death Summary report: N

    HT STEELCORE 18

    MDR report key: 9317454 · Received November 13, 2019

    Report

    Report Number
    2024168-2019-13524
    Event Type
    Death
    Date Received
    November 13, 2019
    Date of Event
    October 21, 2019
    Report Date
    January 16, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    UDI-DI
    08717648013959
    PMA / PMN Number
    K982876
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS. 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. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE, HI-TORQUE GUIDE WIRES, INSHEET STYLE CE/FDA, STATES: ALL HI-TORQUE GUIDE WIRES ARE INTENDED TO FACILITATE THE PLACEMENT OF BALLOON DILATATION CATHETERS DURING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. IT SHOULD BE NOTED THAT THE DISTAL PORTION OF ALL HI-TORQUE STEELCORE GUIDE WIRES ARE COMPOSED OF A 5-CENTIMETER PLATINUM NICKEL ROUND WIRE RADIOPAQUE TIP COIL AND DO NOT HAVE ANY POLYMER COATING. BASED ON THE PHOTO PROVIDED BY THE ACCOUNT, IT IS UNCLEAR IF THE GUIDE WIRE COILS ARE DAMAGED OR IF COAGULATION OF BLOOD AND/OR CONTRAST ARE PRESENT ON THE WIRE. THERE IS A NOTED BEND ON THE DISTAL END OF THE GUIDE WIRE WHICH IS CONSISTENT WITH THE TIP SHAPE PROCESS DURING PREPARATION. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.H6: PATIENT CODE 2687 REMOVED. DEVICE CODE 2915 REMOVED. DEVICE CODE 1454 REMOVED AND REPLACED WITH 2895.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2019001. THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS. 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. IT SHOULD BE NOTED THAT PER INSTRUCTIONS FOR USE, HI-TORQUE GUIDE WIRES, INSHEET STYLE CE/FDA: ALL HI-TORQUE GUIDE WIRES ARE INTENDED TO FACILITATE THE PLACEMENT OF BALLOON DILATATION CATHETERS DURING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). IN THIS CASE, THE REPORTED VIOLATION OF THE IFU DOES NOT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. IT SHOULD BE NOTED THAT THE DISTAL PORTION OF ALL HI-TORQUE STEELCORE GUIDE WIRES ARE COMPOSED OF A 5-CENTIMETER PLATINUM NICKEL ROUND WIRE RADIOPAQUE TIP COIL AND NO NOT HAVE ANY POLYMER COATING. BASED ON THE PHOTO PROVIDED BY THE ACCOUNT, IT IS UNCLEAR IF THE GUIDE WIRE COILS ARE DAMAGED OR IF COAGULATION OF BLOOD AND/OR CONTRAST ARE PRESENT ON THE WIRE. THERE IS A NOTED BEND ON THE DISTAL END OF THE GUIDE WIRE WHICH IS CONSISTENT WITH THE TIP SHAPE PROCESS DURING PREPARATION. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. EXEMPTION NUMBER E2019001 PERMITS NUMBERING SEQUENCE TO BEGIN WITH 10000, TO AVOID DUPLICATION OF REPORT NUMBERS DUE TO PROCESS TRANSITION. THERE MAY BE GAPS IN NUMBERING FOR REPORTS SUBMITTED DURING THE TRANSITION PERIOD.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 1/14/2020: THE INITIALLY REPORTED "NICKED COATING" WAS CLARIFIED TO BE COAGULATED BLOOD AND CONTRAST. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED: ON (B)(6) 2019, THE PATIENT WAS FOUND DECEASED AT HER RESIDENCE. IT WAS REPORTED AS SUDDEN DEATH AND THE CAUSE IS UNKNOWN. AN AUTOPSY WAS NOT DONE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO IMPLANT A CARDIOMEMS SENSOR IN THE HEART. THE SENSOR AND DELIVERY CATHETER WERE ADVANCED OVER THE HI-TORQUE STEELCORE 18 GUIDEWIRE AND DURING REMOVAL, THE GUIDE WIRE APPEARED TO HAVE A PEELED POLYMER COATING CAUSING RESISTANCE WITH THE DELIVERY CATHETER AND THEREFORE MOVING THE SENSOR OUT OF PLACE. THE PHYSICIAN WAS ABLE TO MANIPULATE THE DELIVERY CATHETER AND GUIDEWIRE TO POSITION SENSOR BACK TO DESIRED POSITION USING A NON-ABBOTT GUIDING CATHETER. THE DELIVERY CATHETER AND GUIDE WIRE WERE REMOVED SEPARATELY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112691 HT STEELCORE 18 GUIDE WIRE DQX ABBOTT VASCULAR 8121261 08717648013959

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| O SWAN GANZ CATHETER.