BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014

    MDR report key: 1933079 · Received December 20, 2010

    Report

    Report Number
    2939204-2010-01160
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - STUCK IN STENT.

    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 FOR STUCK IN STENT WERE FOUND IN THIS LOT. VISUAL INSPECTION OF THE RETURNED CATHETER REVEALED THE GUIDEWIRE EXIT PORT WAS LIFTED. FLUID WAS OBSERVED INSIDE THE TELESCOPE AND DISTAL TIP ASSEMBLY. NO FLUID WAS FOUND INSIDE THE HUB AND NO KINK WAS OBSERVED IN THE SHEATH ASSEMBLY. ONE HUB WING WAS BENT AND APPEARS TO BE UNRELATED TO THE STUCK IN STENT. HANDLING DAMAGE IS THE LIKELY CAUSE OF THE BENT HUB WING. A TEST GUIDEWIRE WAS INSERTED AND NO INDICATION OF RESISTANCE IN TRACKING THE GUIDEWIRE INTO THE CATHETER WAS NOTED. IMAGING CORE WIND UP IN THE TELESCOPE ASSEMBLY WAS OBSERVED. WIND UP, A DESIGN ISSUE, IS A RESULT OF THE IMAGING CORE BEING CONSTRAINED WHICH BREAKS THE SIGNAL PATHWAY LEADING TO IMAGE ISSUES. THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) REVEALED 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 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

    PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED IN A LESION WITH MILD CALCIFICATION AND MODERATE TORTUOSITY IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A STENT WAS IMPLANTED AND THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS USED TO IMAGE STENT PLACEMENT. THE STENT WAS FULLY DEPLOYED AND WELL APPOSED. UPON REMOVAL MILD RESISTANCE WAS FELT AND THE IVUS CATHETER BECAME CAUGHT ON THE STENT. THE PHYSICIAN PULLED THE IVUS CATHETER RELEASING THE IVUS CATHETER WHICH WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER IVUS CATHETER. THE PATIENT CONDITION WAS REPORTED AS "GOOD".

    Description of Event or Problem · 1

    PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED IN A LESION WITH MILD CALCIFICATION AND MODERATE TORTUOSITY IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A STENT WAS IMPLANTED AND THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS USED TO IMAGE STENT PLACEMENT. THE STENT WAS FULLY DEPLOYED AND WELL APPOSED. UPON REMOVAL MILD RESISTANCE WAS FELT AND THE IVUS CATHETER BECAME CAUGHT ON THE STENT. THE PHYSICIAN PULLED THE IVUS CATHETER RELEASING THE IVUS CATHETER WHICH WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER IVUS CATHETER. THE PATIENT CONDITION WAS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014 CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT H749390140 13810457

    Patients

    Seq Age Sex Outcome Treatment
    1 ST. JUDE MEDICAL SION GUIDE WIRE| GOODMAN LACROSSE BALLOON CATHETER| MEDTRONIC LAUNCHER GUIDE CATHETER| ABBOTT XIENCE V STENT