BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVOLUTION 45MHZ IVUS IMAGING CATHETER

    MDR report key: 7089479 · Received December 6, 2017

    Report

    Report Number
    2939520-2017-00088
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    November 7, 2017
    Report Date
    November 7, 2017
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    UDI-DI
    00184360000358
    PMA / PMN Number
    K080891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REFERENCE: (B)(4). THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. ATTEMPTS TO OBTAIN PATIENT INFORMATION WAS UNSUCCESSFUL AS THE FACILITY DECLINED TO PROVIDE THE INFORMATION. ADDITIONAL INFORMATION OBTAINED INDICATED NO DAMAGE WAS OBSERVED DURING PREP. RESISTANCE WAS FELT. ALL PORTIONS OF THE DEVICE APPEARED ACCOUNTED FOR AFTER REMOVAL FROM THE PATIENT. CATHETER DEVICE WAS REMOVED AS A SYSTEM. TREATMENT WAS COMPLETED BY THE PROCEDURE. THE IMPLANT OR EXPLANT DATES ARE NOT APPLICABLE TO THIS DEVICE. THE RETURNED DEVICE WAS RECEIVED IN THREE PIECES WITH THE GUIDE WIRE STILL ATTACHED. THE INNER TELESCOPE WAS BROKEN NEAR THE TELESCOPE PROXIMAL STRAIN RELIEF. THE PROXIMAL SHAFT WAS ALSO BROKEN AT 98MM DISTAL TO THE DISTAL TELESCOPE STRAIN RELIEF. THERE WAS INDENTATION NEAR THE PROXIMAL END BREAK OF THE SHAFT AND THE GUIDEWIRE WAS STUCK AT THIS LOCATION. THE SHAFT WAS FLATTENED AT THE DISTAL AND PROXIMAL END BREAKS, INDICATING THAT THE SHAFT WAS KINKED PRIOR TO THE SEPARATION. DEVICE MANIPULATION, IMPACT AND APPLIED PRESSURE ASSOCIATED WITH USE CAN AFFECT THE INTEGRITY OF THE DEVICE. UNFORTUNATELY, WE COULD NOT CONCLUSIVELY DETERMINE WHEN OR HOW THE DAMAGE OCCURRED THE INSTRUCTIONS FOR USE (IFU) WARNS, DO NOT ADVANCE THE CATHETER IF RESISTANCE IS ENCOUNTERED. THE CATHETER SHOULD NEVER BE FORCIBLY INSERTED INTO LUMENS NARROWER THAN THE CATHETER BODY OR FORCED THROUGH A TIGHT STENOSIS. THE IFU CAUTIONS THE DEVICE IS A DELICATE SCIENTIFIC INSTRUMENT AND SHOULD BE TREATED AS SUCH. THE IFU CONTRAINDICATES USE IN VESSELS WITH SEVERE ARTERIAL CALCIFICATION. 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 DURING A CORONARY THERAPEUTIC PROCEDURE THAT DURING INSERTION PRIOR TO CROSS[ING] THE SEVERELY CALCIFIED LESION INSIDE THE BODY THE CATHETER WAS TRAPPED AND COULD NOT BE MOVED BACK. THE INNER CATHETER (DRIVE CABLE, ETC.) WAS REMOVED FROM THE CONNECTOR AND A GW (GUIDE WIRE) WAS INSERTED INTO THE OUTER CATHETER FROM THE CONNECTOR. THE GW AND THE CATHETER WERE REMOVED TOGETHER AS A SYSTEM FROM THE BODY. THERE WAS NO PATIENT INJURY. VESSEL: #7 / CALCIFICATION: SEVERE. THIS EVENT IS BEING REPORTED BECAUSE ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE CATHETER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867716 REVOLUTION 45MHZ IVUS IMAGING CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCANO CORPORATION 89000 0035 50104904 00184360000358

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention