BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERRATA PRESSURE GUIDE WIRE

    MDR report key: 7152201 · Received December 28, 2017

    Report

    Report Number
    2939520-2017-00096
    Event Type
    Injury
    Date Received
    December 28, 2017
    Date of Event
    November 29, 2017
    Report Date
    November 30, 2017
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQX
    UDI-DI
    00845225002435
    PMA / PMN Number
    K131288
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. THE CUSTOMER DECLINED TO PROVIDE PATIENT INFORMATION. NO DAMAGE WAS OBSERVED DURING PREP. RESISTANCE WAS FELT DURING THE PROCEDURE. THE DEVICE WAS REMOVED BY ITSELF, NOT AS A SYSTEM. TREATMENT WAS COMPLETED BY THE PROCEDURE. NO TESTS/LABORATORY DATA WAS AVAILABLE. OTHER RELEVANT DATA: NO INFORMATION WAS AVAILABLE. THE IMPLANT OR EXPLANT DATES ARE NOT APPLICABLE TO THIS DEVICE. VISUAL AND MICROSCOPIC INSPECTION WERE PERFORMED ON THE RETURNED DEVICE. THE ENTIRETY OF THE WIRE WAS INTACT. THE DISTAL TIP WAS WAVY AND THE DISTAL COIL WAS STRETCHED AND BUNCHED. THIS DAMAGE LIKELY OCCURRED AS A RESULT OF MECHANICAL STRAIN DURING THE PROCEDURE WHILE THE USER ATTEMPTED TO FREE THE DEVICE FROM BEING STUCK. PER USER REPORT, DURING CROSSING THE LESION, THE DEVICE BECAME STUCK IN A SMALL BRANCH. ANOTHER DEVICE WAS USED TO REMOVE THE WIRE. DAMAGE TO THE DEVICE IS CONSISTENT WITH THE REPORTED FAILURE. UNFORTUNATELY, WE WERE UNABLE TO CONCLUSIVELY DETERMINE HOW THE DEVICE INITIALLY BECAME STUCK. INSTRUCTIONS FOR USE (IFU) WARNS TO NEVER ADVANCE, TORQUE OR RETRACT A PRESSURE GUIDE WIRE WHICH MEETS SIGNIFICANT RESISTANCE. THE IFU ALSO CAUTIONS THE PRESSURE GUIDE WIRE SHOULD NOT BE ADVANCED IF RESISTANCE IS ENCOUNTERED. THE WIRE SHOULD NEVER BE FORCIBLY PUSHED INTO A VESSEL. ANY TIME THAT RESISTANCE IS ENCOUNTERED, THE WIRE SHOULD BE WITHDRAWN UNDER FLUOROSCOPIC GUIDANCE. IN SOME INSTANCES, THE WIRE MAY KINK AND MUST BE REMOVED. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THERE WERE NO NONCONFORMING MATERIAL REPORTS OR DEVIATIONS NOTED THAT WOULD CONTRIBUTE TO THE REPORTED FAILURE MODE. THIS COMPLAINT WILL BE MONITORED AS PART OF COMPLAINT DATA ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY PROCEDURE, WHEN CROSSING THE LESION INSIDE THE BODY SOME RESISTANCE WAS MET AND THE WIRE GOT STUCK IN A SMALL BRANCH. ANOTHER MANUFACTURERS WIRE WAS USED AND THE [MANUFACTURER'S] WIRE COULD REMOVE FROM THE BODY. THERE WAS NO PATIENT INJURY. PATIENT RELEASED AS EXPECTED IN STABLE CONDITION. VESSEL: RCA#3, ARTERY OCCLUSION: 50%, TORTUOUSNESS: SLIGHTLY. THIS EVENT IS BEING REPORTED BECAUSE ADDITIONAL INTERVENTION WAS PERFORMED IN AN ATTEMPT TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930287 VERRATA PRESSURE GUIDE WIRE WIRE, GUIDE, CATHETER DQX VOLCANO CORPORATION 10185 0243 50116192 00845225002435

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention