BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICROSS 40 MHZ CORONARY IMAGING CATHETER

    MDR report key: 1659183 · Received April 14, 2010

    Report

    Report Number
    2939204-2010-00649
    Event Type
    Injury
    Date Received
    April 14, 2010
    Date of Event
    March 23, 2010
    Report Date
    April 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) NEW CODE REQUEST HAS BEEN SUBMITTED FOR STUCK IN STENT.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS COULD NOT BE PERFORMED DUE TO DEVICE DISPOSAL. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THE LOT AND NO ISSUES OR DISCREPANCIES WERE FOUND. NO SIMILAR COMPLAINTS BY EVENT DESCRIPTION WERE FOUND IN THE SAME LOT. THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) WERE REVIEWED AND REVEALED THAT THE LABELING AND/OR DFU CONTAINS THESE WARNINGS: NEVER ADVANCE OR WITHDRAW THE IMAGING CATHETER WITHOUT FLUOROSCOPIC VISUALIZATION BECAUSE IT MAY CAUSE VESSEL INJURY OR PATIENT COMPLICATIONS. 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. WHEN ADVANCING THE CATHETER THROUGH A STENTED VESSEL, CATHETERS THAT DO NOT COMPLETELY ENCAPSULATE THE GUIDEWIRE MAY ENGAGE THE STENT BETWEEN THE JUNCTION OF THE CATHETER AND GUIDEWIRE, RESULTING IN ENTRAPMENT OF CATHETER/GUIDEWIRE, CATHETER TIP SEPARATION, AND/OR STENT DISLOCATION. WHEN READVANCING A GUIDEWIRE AFTER DEPLOYMENT OF STENT(S), AT NO TIME SHOULD A CATHETER BE ADVANCED ACROSS A GUIDEWIRE THAT MAY BE PASSING BETWEEN ONE OR MORE STENT STRUTS. A GUIDEWIRE MAY EXIT BETWEEN ONE OR MORE STENT STRUTS WHEN RECROSSING STENT(S). SUBSEQUENT ADVANCEMENT OF THE CATHETER COULD CAUSE ENTANGLEMENT BETWEEN THE CATHETER AND THE STENT(S), RESULTING IN ENTRAPMENT OF CATHETER/GUIDEWIRE, CATHETER TIP SEPARATION, AND/OR STENT DISLOCATION. USE CAUTION WHEN REMOVING THE CATHETER FROM A STENTED VESSEL. INADEQUATELY APPOSED STENTS, OVERLAPPING STENTS, AND/OR SMALL STENTED VESSELS WITH DISTAL ANGULATION MAY LEAD TO ENTRAPMENT OF THE CATHETER WITH THE STENT UPON RETRACTION. WHEN RETRACTING THE CATHETER, ENSURE THAT THE SHORT RAIL DISTAL TIP IS PARALLEL TO THE GUIDEWIRE. SEPARATION OR BENDING OF THE GUIDEWIRE MAY RESULT IN KINKING OF THE GUIDEWIRE, DAMAGE TO THE CATHETER DISTAL TIP, AND/OR VESSEL INJURY. THE LOOPED GUIDEWIRE OR DAMAGED TIP MAY CATCH ON THE STENT STRUT, RESULTING IN ENTRAPMENT. THE REVIEW OF 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 AND THE ANATOMICAL AND PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, THE ROOT CAUSE OF THE STUCK ON STENT HAS BEEN DETERMINED TO BE DUE TO OPERATIONAL CONTEXT. THE MANUFACTURER WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CORONARY STENT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY. AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS USED TO IMAGE THE STENT PLACEMENT. WHEN THE PHYSICIAN WAS FINISHED IMAGING AND WITHDREW THE IVUS CATHETER, IT BECAME CAUGHT ON THE STENT. A GUIDEWIRE WAS PLACED ALONG SIDE THE IVUS CATHETER TO SUCCESSFULLY RELEASE THE IVUS CATHETER FROM THE STENT. THE PATIENT CONDITION IS REPORTED TO BE ¿FINE¿.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CORONARY STENT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY. AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS USED TO IMAGE THE STENT PLACEMENT. WHEN THE PHYSICIAN WAS FINISHED IMAGING AND WITHDREW THE IVUS CATHETER, IT BECAME CAUGHT ON THE STENT. A GUIDEWIRE WAS PLACED ALONG SIDE THE IVUS CATHETER TO SUCCESSFULLY RELEASE THE IVUS CATHETER FROM THE STENT. THE PATIENT CONDITION IS REPORTED TO BE ¿FINE¿.

    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 13183872

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention CORONARY STENT (MANUFACTURER UNKNOWN)