BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014

    MDR report key: 1964308 · Received January 19, 2011

    Report

    Report Number
    2939204-2011-00018
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    December 26, 2010
    Report Date
    December 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED NOTHING RELEVANT TO THE REPORTED EVENT. NO SIMILAR COMPLAINTS WERE FOUND IN THE REPORTED LOT. VISUAL ANALYSIS OF THE RETURNED UNIT OBSERVED BLOODSTAIN INSIDE OF THE DISTAL TIP ASSEMBLY AND FLUID INSIDE THE TELESCOPE ASSEMBLY. NO FLUID WAS FOUND INSIDE THE HUB. KINKS WERE OBSERVED IN THE SHEATH ASSEMBLY. A KINK WAS OBSERVED ON THE RETURNED GUIDEWIRE WHICH ALSO APPEARS TO BE STRETCHED. THE GUIDEWIRE EXIT PORT WAS LIFTED. A TEST GUIDEWIRE (0.014") WAS INSERTED AND NO INDICATION OF RESISTANCE IN TRACKING THE GUIDEWIRE INTO THE CATHETER WAS NOTED. THE TIP END OF THE RETURNED CATHETER APPEARS TO BE DAMAGED. IT IS LIKELY THE OBSERVED GUIDEWIRE EXIT PORT DAMAGE, DISTAL TIP DAMAGE, AND KINKS WERE ALL A RESULT OF MANIPULATION OF THE CATHETER IN ATTEMPTS TO FREE THE DEVICE FROM THE STENT. IMAGING CORE WIND UP IN THE TELESCOPE ASSEMBLY WAS OBSERVED DURING VISUAL ANALYSIS. WIND UP, A DESIGN ISSUE, IS A RESULT OF THE IMAGING CORE BEING CONSTRAINED WHICH BREAKS THE SIGNAL PATHWAY LEADING TO THE LOSS OF AN IMAGE, UNRELATED TO THE STUCK IN STENT. THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) WERE REVIEWED AND REVEALED THAT THE LABELING AND/OR DFU CONTAINS GUIDANCE AND WARNINGS: MATERIALS AND EQUIPMENT: GUIDEWIRE, 0.36 MM (0.014 IN) MAX. 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 EVIDENCE THAT THE CATHETER MAY HAVE BEEN USED AGAINST THE DFU, HOWEVER, IT IS UNLIKELY THE USE OF A GUIDEWIRE (.017) LARGER THAN RECOMMENDED CONTRIBUTED TO THE CATHETER TO BECOMING STUCK IN THE STENT OR TO THE DAMAGED DISTAL TIP. BASED ON THE CONDITION OF THE RETURNED CATHETER, THE EVENT DESCRIPTION, AND THE ANATOMICAL AND PROCEDURAL FACTORS ENCOUNTERED DURING THIS PROCEDURE, THE PROBABLE ROOT CAUSE OF OPERATIONAL CONTEXT WAS ASSIGNED TO THIS COMPLAINT FOR THE CATHETER STUCK IN STENT AND TIP DAMAGED ISSUE. THE MANUFACTURER WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS PRODUCT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A 99% STENOSED, MODERATELY TORTUOUS AND MILDLY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) MIDDLE. THE LESION WAS PRE-DILATED WITH A BALLOON. AN INTRAVASCULAR ULTRASOUND (IVUS) IMAGING CATHETER WAS USED TO IMAGE THE LESION. A STENT WAS PLACED IN THE LESION AND THE IVUS WAS USED AGAIN TO VIEW THE STENT PLACEMENT. ACCORDING TO THE PHYSICIAN THE PROXIMAL PORTION OF THE STENT DID NOT HAVE GOOD APPOSITION; HOWEVER, THE DISTAL PORTION OF THE STENT HAD GOOD APPOSITION. THE PHYSICIAN FELT STRONG RESISTANCE DURING THE WITHDRAWAL OF THE IVUS. FLUOROSCOPY CONFIRMED THAT THE IVUS CATHETER HAD BECOME STUCK IN THE STENT, AND THAT THE STENT HAD MIGRATED TO THE LEFT MAIN CORONARY ARTERY (LMCA). THE PHYSICIAN REMOVED THE CATHETER AND GUIDE WIRE AS A SINGLE UNIT FROM THE PATIENT, NOTING THE TIP OF THE IVUS CATHETER WAS DAMAGED. THE PHYSICIAN CHANGED THE 6FR GUIDE CATHETER TO A 10FR GUIDE CATHETER AND RETRIEVED THE STENT WITH A GOOSENECK SNARE. A NEW STENT WAS PLACED IN THE LAD MIDDLE AGAIN TO COMPLETE THE PROCEDURE. THE PATIENT IS REPORTED TO BE IN "GOOD" CONDITION.

    Description of Event or Problem · 1

    A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A 99% STENOSED, MODERATELY TORTUOUS AND MILDLY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) MIDDLE. THE LESION WAS PRE-DILATED WITH A BALLOON. AN INTRAVASCULAR ULTRASOUND (IVUS) IMAGING CATHETER WAS USED TO IMAGE THE LESION. A STENT WAS PLACED IN THE LESION AND THE IVUS WAS USED AGAIN TO VIEW THE STENT PLACEMENT. ACCORDING TO THE PHYSICIAN THE PROXIMAL PORTION OF THE STENT DID NOT HAVE GOOD APPOSITION; HOWEVER, THE DISTAL PORTION OF THE STENT HAD GOOD APPOSITION. THE PHYSICIAN FELT STRONG RESISTANCE DURING THE WITHDRAWAL OF THE IVUS. FLUOROSCOPY CONFIRMED THAT THE IVUS CATHETER HAD BECOME STUCK IN THE STENT, AND THAT THE STENT HAD MIGRATED TO THE LEFT MAIN CORONARY ARTERY (LMCA). THE PHYSICIAN REMOVED THE CATHETER AND GUIDE WIRE AS A SINGLE UNIT FROM THE PATIENT, NOTING THE TIP OF THE IVUS CATHETER WAS DAMAGED. THE PHYSICIAN CHANGED THE 6FR GUIDE CATHETER TO A 10FR GUIDE CATHETER AND RETRIEVED THE STENT WITH A GOOSENECK SNARE. A NEW STENT WAS PLACED IN THE LAD MIDDLE AGAIN TO COMPLETE THE PROCEDURE. THE PATIENT IS REPORTED TO BE IN GOOD CONDITION.

    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 13833245

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE CATHETER: 6FR MACH 1 FL4, BSC| BALLOON CATHETER: LIFESPEAR 2.5 X 12 MM, UNK| STENT: DRIVER 3.0 X 15 MM, MEDTRONIC| GUIDEWIRE: TGV FLOPPY, (B)(4)