BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014

    MDR report key: 2078575 · Received May 5, 2011

    Report

    Report Number
    2939204-2011-00253
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 18, 2011
    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

    CUSTOMER NOTIFICATION HAS BEEN DISTRIBUTED TO JAPANESE CUSTOMERS AND SENT TO THE PMDA. FDA REPORT OF CORRECTION AND REMOVAL WAS FILED MARCH 14, 2011 (REFERENCE # 9912058-3/3/14/2011-0001-C). 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 THE DISTAL TIP END WAS BROKEN OFF (APPROXIMATELY 2.6 CM) AND MISSING. IMAGING CORE WIND UP IN THE TELESCOPE ASSEMBLY WAS OBSERVED AND APPEARS TO BE UNRELATED TO THE TIP BREAK. WIND UP, A DESIGN ISSUE, IS A RESULT OF THE IMAGING CORE BEING CONSTRAINED WHICH BREAKS THE SIGNAL PATHWAY LEADING TO IMAGE ISSUES. A SAMPLE OF THE DEVICE WAS SENT TO AN OUTSIDE VENDOR FOR OXIDATION ANALYSIS. BASED ON THE INFORMATION GATHERED, HIGH LEVELS OF OXIDATION AT THE SURFACE AND THROUGHOUT THE TESTED SAMPLE WERE NOTED. THE DEVICE LABELING AND DIRECTIONS FOR USE (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 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

    PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED IN A 90% STENOSED LESION WITH SLIGHT CALCIFICATION AND SEVERE TORTUOSITY IN THE RIGHT CORONARY ARTERY (RCA) PROXIMAL. THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS SUCCESSFULLY USED TO IMAGE THE LESION; HOWEVER, SLIGHT RESISTANCE WAS NOTED WHILE INSERTING AND SEVERE RESISTANCE WHILE WITHDRAWING THE IVUS CATHETER. POBA WAS PERFORMED, A STENT WAS IMPLANTED AND THEN POST-INFLATION WAS PERFORMED. THE PHYSICIAN ATTEMPTED TO REMOVE THE IVUS CATHETER FROM THE PROTECTOR HOOP, PREPARING TO RE-ADVANCE THE IVUS CATHETER TO IMAGE THE STENT PLACEMENT, WHEN THE DISTAL PART OF THE IVUS CATHETER JUMPED OUT FROM THE HOOP AT WHICH POINT APPROXIMATELY 3CM OF THE DISTAL TIP OF THE IVUS CATHETER DETACHED. THE PROCEDURE WAS COMPLETED WITH A NEW IVUS CATHETER. THE PATIENT STATUS IS REPORTED AS "GOOD".

    Description of Event or Problem · 1

    PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED IN A 90% STENOSED LESION WITH SLIGHT CALCIFICATION AND SEVERE TORTUOSITY IN THE RIGHT CORONARY ARTERY (RCA) PROXIMAL. THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS SUCCESSFULLY USED TO IMAGE THE LESION; HOWEVER, SLIGHT RESISTANCE WAS NOTED WHILE INSERTING AND SEVERE RESISTANCE WHILE WITHDRAWING THE IVUS CATHETER. POBA WAS PERFORMED, A STENT WAS IMPLANTED AND THEN POST-INFLATION WAS PERFORMED. THE PHYSICIAN ATTEMPTED TO REMOVE THE IVUS CATHETER FROM THE PROTECTOR HOOP, PREPARING TO RE-ADVANCE THE IVUS CATHETER TO IMAGE THE STENT PLACEMENT, WHEN THE DISTAL PART OF THE IVUS CATHETER JUMPED OUT FROM THE HOOP AT WHICH POINT APPROXIMATELY 3CM OF THE DISTAL TIP OF THE IVUS CATHETER DETACHED. THE PROCEDURE WAS COMPLETED WITH A NEW IVUS CATHETER. THE PATIENT STATUS IS 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 13754744

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO RUNTHROUGH GUIDE WIRE| MEDTRONIC 6F LAUNCHER SAL1 GUIDE CATHETER