BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICROSS 40 MHZ CORONARY IMAGING CATHETER

    MDR report key: 2083601 · Received May 10, 2011

    Report

    Report Number
    2939204-2011-00277
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Removal / Correction Number
    90657289-FA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: DEVICE AVAIL. ADD'L MFR. NARRATIVE: 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 APPROXIMATELY 2.5CM OF THE DISTAL TIP ASSEMBLY WITH THE RO MARKER WAS BROKEN OFF AND MISSING WHEN RECEIVED. THE CATHETER WAS RETURNED IN THREE PIECES. THE FIRST PIECE MEASURED 2.2CM LONG, THE SECOND PIECE MEASURED 3.3CM LONG AND THE REST OF THE CATHETER ASSEMBLY MEASURED 162.4CM LONG. IMAGE CHARACTERIZATION TESTING COULD NOT BE PERFORMED BASED ON THE RETURNED CONDITION OF THE CATHETER. THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) CONTAINS THESE COMPLICATIONS, WARNINGS, AND PRECAUTIONS: COMPLICATIONS: EMBOLISM (AIR, FOREIGN BODY, TISSUE OR THROMBUS). 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. PRECAUTIONS: IF DIFFICULTY IN BACKLOADING THE GUIDEWIRE INTO THE DISTAL END OF THE CATHETER IS ENCOUNTERED, INSPECT THE GUIDEWIRE EXIT PORT FOR DAMAGE BEFORE INSERTING THE CATHETER INTO THE VASCULATURE. THE USE OF A DAMAGED GUIDEWIRE EXIT PORT COULD INCREASE THE RESISTANCE OF CATHETER ADVANCEMENT OR WITHDRAWAL. THE REVIEW OF THE DEVICE LABELING FOUND NO EVIDENCE OR INDICATION THAT THE CATHETER WAS USED AGAINST THE LABELING AND/OR DIRECTIONS FOR USE. THE CAUSE OF THE TIP DETACHMENT HAS BEEN DETERMINED TO BE OXIDATION OF THE CATHETER WHICH CAUSES EMBRITTLEMENT, INCREASING THE LIKELIHOOD OF TIP DETACHMENTS OF THIS NATURE. A ROOT CAUSE OF DESIGN WAS ASSIGNED.

    Description of Event or Problem · 1

    AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS USED IN THE LEFT MAIN (LM) AND LEFT ANTERIOR DESCENDING (LAD) ARTERIES TO IMAGE A LESION WHICH WAS NON-TORTUOUS, CALCIFIED WITH 90% STENOSIS. RESISTANCE WAS MET DURING ADVANCING THE IVUS CATHETER MIDWAY INTO THE VESSEL. THE CATHETER WAS REMOVED WITHOUT RESISTANCE AND STENTS WERE PLACED. THE PHYSICIAN WAS RELOADING THE IVUS CATHETER ONTO THE GUIDEWIRE, INTENDING TO IMAGE THE STENT PLACEMENT, WHEN THE DISTAL TIP OF IVUS CATHETER BROKE OFF IN HIS HANDS. THE PHYSICIAN OBTAINED A NEW IVUS CATHETER TO PROCEED WITH IMAGING AND NOTED "EVERYTHING WAS FINE". IT WAS THEN OBSERVED THAT A RADIOPAQUE MARKER, BELIEVED TO BE FROM THE INITIAL CATHETER, HAD REMAINED IN THE VERY DISTAL LAD. DUE TO THE LOCATION THE DECISION WAS MADE TO LEAVE IT IN THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED AS "STABLE WITHOUT ISCHEMIA".

    Description of Event or Problem · 1

    AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS USED IN THE LEFT MAIN (LM) AND LEFT ANTERIOR DESCENDING (LAD) ARTERIES TO IMAGE A LESION WHICH WAS NON-TORTUOUS, CALCIFIED WITH 90% STENOSIS. RESISTANCE WAS MET DURING ADVANCING THE IVUS CATHETER MIDWAY INTO THE VESSEL. THE CATHETER WAS REMOVED WITHOUT RESISTANCE AND STENTS WERE PLACED. THE PHYSICIAN WAS RELOADING THE IVUS CATHETER ONTO THE GUIDEWIRE, INTENDING TO IMAGE THE STENT PLACEMENT, WHEN THE DISTAL TIP OF IVUS CATHETER BROKE OFF IN HIS HANDS. THE PHYSICIAN OBTAINED A NEW IVUS CATHETER TO PROCEED WITH IMAGING AND NOTED "EVERYTHING WAS FINE". IT WAS THEN OBSERVED THAT A RADIOPAQUE MARKER, BELIEVED TO BE FROM THE INITIAL CATHETER, HAD REMAINED IN THE VERY DISTAL LAD. DUE TO THE LOCATION THE DECISION WAS MADE TO LEAVE IT IN THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED AS "STABLE WITHOUT ISCHEMIA".

    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 13612369

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GUIDE CATHETER, UNKNOWN| GUIDEWIRE, UNKNOWN