BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION 45MHZ IVUS IMAGING CATHETER

    MDR report key: 6175986 · Received December 15, 2016

    Report

    Report Number
    2939520-2016-00088
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    September 1, 2016
    Report Date
    September 5, 2016
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    PMA / PMN Number
    K080891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS TO OBTAIN PATIENT IDENTIFICATION, AGE AND WEIGHT WERE UNSUCCESSFUL. ATTEMPTS TO OBTAIN THE PATIENT INFORMATION WERE MADE VIA EMAIL. ALL REASONABLY KNOWN PATIENT INFORMATION IS INCLUDED IN THIS REPORT. NO TESTS/LABORATORY DATA WAS AVAILABLE. NO INFORMATION WAS AVAILABLE. THE 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 ALSO CAUTIONS TO AVOID ANY SHARP BENDS, PINCHING, OR CRUSHING OF THE CATHETER.

    Description of Event or Problem · 1

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED WHILE INSERTING THE CATHETER DEVICE INTO THE PATIENT, THE PHYSICIAN FOUND THE SHAFT BEHIND THE TRANSDUCER WAS STICKING OUT. THE DEVICE WAS REMOVED AND ANOTHER CATHETER DEVICE OF SAME PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY AND THE PATIENT WAS DISCHARGED AS EXPECTED. THE DEVICE WAS INSPECTED DURING PREP AND NO DAMAGE WAS OBSERVED. NO SHAPING TOOL WAS USED. RESISTANCE WAS FELT INSIDE THE BODY AND THE DEVICE STUCK ON THE GUIDE CATHETER (GC). THE DEVICE WAS REMOVED ON ITS OWN. THE PHYSICIAN NOTED THE DISTAL SHAFT WAS FLARED AFTER REMOVAL FROM PATIENT. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE AND THERE WERE NO ADVERSE EVENTS. THE RETURNED CATHETER DEVICE WAS VISUALLY INSPECTED AND THERE WAS NO SHAFT SEPARATION ON THE RETURNED DEVICE. WHEN MICROSCOPICALLY INSPECTED, IT WAS OBSERVED THAT THE DISTAL SHAFT WAS FLARED AND TORN AT THE DISTAL END OF THE MONORAIL SECTION AND SANGUINEOUS MATERIAL WAS PRESENT AT THIS LOCATION. THE DISTAL TIP SECTION OF THE DISTAL SHAFT WAS PARTIALLY SCRAPED. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE TEAR AND FLARE OBSERVED IN THE DISTAL END OF THE MONORAIL SECTION WAS MOST LIKELY A RESULT OF EFFORTS TO REMOVE THE GUIDEWIRE FROM THE CATHETER. WE WERE UNABLE TO CONCLUSIVELY DETERMINE HOW THE DAMAGE OCCURRED. THIS EVENT IS BEING REPORTED BECAUSE A TORN/FLARED MONORAIL HAS THE POTENTIAL TO CAUSE HARM IF THE EVENT WERE TO RECUR. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829649 REVOLUTION 45MHZ IVUS IMAGING CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCANO CORPORATION 89000 0035 50060567

    Patients

    Seq Age Sex Outcome Treatment
    1