BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE ADVANCE GUIDE WIRE

    MDR report key: 1887712 · Received October 26, 2010

    Report

    Report Number
    2024168-2010-02262
    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). THROMBOSIS AND THE ADDITIONAL THERAPY/NON-SURGICAL TREATMENT IS A KNOWN ADVERSE PATIENT EVENT AS LISTED IN THE NO FAULT RISK ASSESSMENT MATRIX FOR THE DEVICE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE AND DESIGN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED AND THE LOT NUMBER WAS NOT PROVIDED. A F/U WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION. THE HI-TORQUE PILOT (PART 1010481, LOT 9121991) AND HI-TORQUE PROGRESS (PART 1011842, LOT 0022291) ARE BEING FILED UNDER SEPARATE 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".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE ADVANCE GUIDE WIRE GUIDE WIRE DQX ABBOTT VASCULAR - CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention STENT: FIREBIRD 3.0 X 23MM| (PART 1011842, LOT 0022291)| HI-TORQUE PILOT (1010481-H, 9121991)| SHEALTH: 7 FR| DILATATION CATHETER: RYUJIN 1.25X15MM| GUIDE WIRE: HI-TORQUE PROGRESS| INFLATION: PPK| OTHER: TERUMO FINECROSS MICRO CATHETER| GUIDE CATH: JCL 4 - 7 FR| HEPARIN