BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICROSS 40 MHZ CORONARY IMAGING CATHETER

    MDR report key: 2080014 · Received May 6, 2011

    Report

    Report Number
    2939204-2011-00280
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THE LOT AND NO ISSUES OR DISCREPANCIES WERE FOUND. NO SIMILAR COMPLAINTS WERE FOUND IN THE LOT. VISUAL INSPECTION OF THE RETURNED CATHETER REVEALED THE GUIDEWIRE EXIT PORT WAS LIFTED AND RIPPED, LIKELY AS A RESULT OF THE EFFORTS TO REMOVE THE CATHETER. A TEST GUIDEWIRE WAS INSERTED AND NO INDICATION OF RESISTANCE IN TRACKING THE GUIDEWIRE INTO THE CATHETER WAS NOTED. CORROSION AND MOISTURE WAS OBSERVED INSIDE THE HUB ASSEMBLY AND FLUID WAS LEAKING INSIDE THE HUB WHEN THE CATHETER WAS FLUSHED WHICH IS NOT RELATED TO THE STUCK IN STENT. IMAGE CHARACTERIZATION TESTING REVEALED A GOOD SQUARE IMAGE IN THE SYSTEM AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) CONTAINS THESE WARNINGS: 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. A CATHETER THAT IS FORCIBLY ADVANCED MAY CAUSE CATHETER DAMAGE RESULTING IN VESSEL INJURY OR PATIENT COMPLICATIONS. IF RESISTANCE IS MET UPON WITHDRAWAL OF THE CATHETER, VERIFY RESISTANCE USING FLUOROSCOPY, THEN REMOVE THE ENTIRE SYSTEM SIMULTANEOUSLY. A CATHETER THAT IS FORCIBLY REMOVED MAY CAUSE VESSEL INJURY OR PATIENT COMPLICATIONS. THE REVIEW OF THE DEVICE LABELING FOUND NO EVIDENCE OR INDICATION THAT THE CATHETER WAS USED AGAINST THE LABELING AND/OR DIRECTIONS FOR USE. BASED ON THE EVENT DESCRIPTION, THE OBSERVED DAMAGE TO THE GUIDEWIRE EXIT PORT, DFU REVIEW AND THE ANATOMICAL AND PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, THE CAUSE OF THE STUCK IN STENT HAS BEEN DETERMINED TO BE DUE TO OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT WHILE WITHDRAWING THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER, THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING, THE CATHETER BECAME CAUGHT IN THE VESSEL, MINIMALLY PROLONGING THE PROCEDURE. THE CATHETER WAS REMOVED TOGETHER WITH THE GUIDEWIRE, GUIDEWIRE EXIT PORT DAMAGE WAS NOTED. NO RESISTANCE OR FRICTION WAS NOTED WHILE ADVANCING THE CATHETER PRIOR TO THE EVENT. THE PATIENT IS REPORTED TO BE "DOING WELL".

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT WHILE WITHDRAWING THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER, THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING, THE CATHETER BECAME CAUGHT IN THE VESSEL, MINIMALLY PROLONGING THE PROCEDURE. THE CATHETER WAS REMOVED TOGETHER WITH THE GUIDEWIRE, GUIDEWIRE EXIT PORT DAMAGE WAS NOTED. NO RESISTANCE OR FRICTION WAS NOTED WHILE ADVANCING THE CATHETER PRIOR TO THE EVENT. THE PATIENT IS REPORTED TO BE "DOING WELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICROSS 40 MHZ CORONARY IMAGING CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT H749518050 14113183

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening GUIDEWIRE (MANUFACTURER UNKNOWN)