BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE PILOT GUIDE WIRE

    MDR report key: 1013123 · Received March 14, 2008

    Report

    Report Number
    2024168-2008-00189
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K984394
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION: PROD PERF ENGINEERING REVIEWED THE INCIDENT INFO. HISTORICAL DATA SHOWS THAT TIP DAMAGE OF THIS NATURE MAY HAPPEN WHEN THE CORE (OR SHAPING RIBBON) IS SUBJECTED TO TENSILE, TORSIONAL OR DUCTILE LOADS BEYOND ITS DESIGN LIMITS CAUSING THE DISTAL TIP TO DETACH. TYPICALLY, THE FRACTURE SITE MORPHOLOGY SHOWS THE CORE (OR SHAPING RIBBON) WAS EXPOSED TO FORCES CONSISTENT WITH THOSE APPLIED THROUGH TORQUING AND MANIPULATION. A GUIDE WIRE BEING OVER TORQUED OR BENT WHILE THE TIP IS TRAPPED WITHIN THE ANATOMY OR ANOTHER DEVICE CAN INTENSIFY THESE FORCES. HOWEVER, BECAUSE THE GUIDE WIRE IN THIS CASE WAS NOT RETURNED, A DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION/PERMANENT DAMAGE. REPORTING RATIONALE: SEPARATED GUIDE WIRE REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: SEPARATED GUIDE WIRE. IT WAS REPORTED THAT A GUIDING CATHETER WAS ENGAGED AND THE PILOT GUIDE WIRE CROSSED THROUGH THE LESION. AFTER USING TWO DIFFERENT DILATATION CATHETERS AND ANOTHER CO'S GUIDE WIRE AS SUPPORT, SEVERAL ATTEMPTS WERE MADE TO CROSS THE LESION. FINALLY, ANOTHER DILATATION CATHETER WAS SELECTED AND WAS INFLATED AT 28 ATM. THE LESION WAS CONFIRMED TO BE EXPLANTED SUFFICIENTLY OVER THE INTRAVASCULAR ULTRA SOUND (IVUS), SO THE PILOT 50 WAS REMOVED FROM THE PT. THE ANGIOGRAM REVEALED THE SEPARATION OF THE PILOT 50; AS THE TIP PART (ABOUT 15 MM) WAS FOUND IN THE VESSEL. A SNARE DEVICE WAS DELIVERED OVER A SECOND PILOT GUIDE WIRE, BUT THE SEPARATED PIECE COULD NOT BE RETRIEVED. A 2.0 MM BALLOON WAS DELIVERED AND INFLATED TO PULL OUT THE SEPARATED PART TOGETHER, BUT IT ALSO FAILED. THE VESSEL DIAMETER WAS 2.0MM AND IT WAS SO SMALL THAT IT WAS HARD TO COLLECT THE SEPARATED PART. ANOTHER CO'S 2.5 X 12 STENT WAS DEPLOYED OVER THE SEPARATED PIECE TO COMPRESS IT BETWEEN THE STENT AND THE VESSEL WALL. ALTHOUGH THE SEPARATED PIECE REMAINED IN THE PT, THE PROCEDURE WAS COMPLETED. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE PILOT GUIDE WIRE 74 DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 7103192

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention APPLO 2.5X15| OTHER: RESOLUTION (IVUS)| DIL CATH, LACROSS 2.0X15| DE SLIP 2.5X9| GUIDE WIRE: STAR| GUIDE CATH: LAUNCHER 6F EBU 3.75| HEARTRAIL 5F ST