BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE PROGRESS 200T GUIDE WIRE

    MDR report key: 1887725 · Received October 26, 2010

    Report

    Report Number
    2024168-2010-02259
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ABBOTT VASCULAR - CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K060449
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REC'D. THE INVESTIGATION IS NOT YET COMPLETED. THE HI-TORQUE PILOT (PART 1010481-H, LOT 9121991) AND ADVANCE (PART AND LOT NUMBER UNK), INDICATED ARE BEING FILED UNDER SEAPARATE MFR#.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ELECTIVE PERCUTANEOUS CORONARY INTERVENTION (PCI) CASE WITH CHRONIC TOTAL OCCLUSION (CTO) AT THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) UNDER THE DRUG ELUTING STENT (DES) PLAN OF TREATMENT, THE CTO LESION WAS TRIED WITH A PILOT 150 GUIDE WIRE (GW), BUT COULD NOT CROSS THEN CHANGED TO A PROGRESS 200T WHICH SUCCESSFULLY PASSED THE LESION. THE PHYSICIAN PLANNED TO STENT WITH A DES AND INSERTED AN ADVANCE GW TO PROTECT A SIDE BRANCH. THE PROGRESS WAS REMOVED FROM THE VESSEL AND WAS REPLACED WITH THE PILOT 150 GW WHICH WAS PREVIOUSLY USED, AND A MICROCATHETER AT THE LAD. THE PHYSICIAN FELT IT WAS DIFFICULT TO MOVE THE GW THROUGH THE GUIDING CATHETER AND, SO REMOVED THE SYSTEM OUT AND FLUSHED THE CLOT FROM THE CATHETER. HE THEN REPEATED THE PROCEDURE. ALSO DILATED THE LESION WITH A NON-ABBOTT DILATATION CATHETER AND A NON-ABBOTT STENT. THERE WAS NO REPORTED PT SEQUELA. THE PHYSICIAN COULD NOT DETERMINE IF DIFFICULTY WITH THE GW OR THE GW COATING OR INTERMEDIATE COIL CONTRIBUTED TO THE "CLOT".

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ELEVATED ACCUTNI RESULTS WITHIN THE RISK STRATIFICATION RANGE FOR TWO PATIENTS GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE PATIENTS WERE HELD AT THE ER FOR OBSERVATION. REPEAT TESTING ON THE ORIGINAL SAMPLE GENERATED RESULTS WITHIN THE NORMAL REFERENCE RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE PROGRESS 200T GUIDE WIRE GUIDE WIRE DQX ABBOTT VASCULAR - CARDIAC THERAPIES NA 0022291

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention HEPARIN| OTHER: TERUMO FINECROSS MICRO CATHETER| GUIDE WIRE: PROGRESS 200T| SHEATH: 7FR| DILATATION CATHETER: RYUJIN 1.25 X 15MM| STENT: FIREBIRD 3.0 X 23MM| ADVANCE:| HI-TORQUE PILOT (PART 1010481-H, LOT 9121991)| INFLATION: PPK| GUIDE CATH: JCL 4 - 7 FR