BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014

    MDR report key: 2102393 · Received May 25, 2011

    Report

    Report Number
    2939204-2011-00281
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 5, 2011
    Report Date
    May 5, 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

    OTHER TEXT: DEVICE EVALUATION HAS COMMENCED, INVESTIGATION IS NOT COMPLETE.

    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 TIP DETACHMENT WERE FOUND IN THE LOT. INSPECTION OF THE RETURNED CATHETER REVEALED THE IMAGING WINDOW WAS DETACHED AT THE LAP JOINT. VISUAL INSPECTION REVEALED ONE HUB WING WAS BROKEN OFF AND MISSING WHEN RECEIVED. HANDLING DAMAGE IS THE LIKELY CAUSE OF THE BROKEN HUB WING AND IS UNRELATED TO THE TIP DETACHMENT. IMAGE CHARACTERIZATION TESTING REVEALED A GOOD SQUARE IMAGE IN THE SYSTEM AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. 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. A ROOT CAUSE OF UNDETERMINABLE WAS ASSIGNED BASED ON THE OBSERVED DAMAGE.

    Description of Event or Problem · 1

    AN INTRAVASCULAR ULTRASOUND (IVUS) IMAGING CATHETER WAS RETURNED FOR AN IMAGING ISSUE, UPON VISUAL ANALYSIS OF THE RETURNED DEVICE THE DISTAL TIP IMAGING WINDOW ASSEMBLY (25.5 CM) WAS FOUND TO BE DETACHED FROM THE CATHETER. IT IS UNKNOWN HOW AND WHEN THE TIP BECAME SEPARATED FROM THE CATHETER. THE PATIENT'S CONDITION WAS STATED AS "GOOD".

    Description of Event or Problem · 1

    AN INTRAVASCULAR ULTRASOUND (IVUS) IMAGING CATHETER WAS RETURNED FOR AN IMAGING ISSUE, UPON VISUAL ANALYSIS OF THE RETURNED DEVICE THE DISTAL TIP IMAGING WINDOW ASSEMBLY (25.5 CM) WAS FOUND TO BE DETACHED FROM THE CATHETER. IT IS UNKNOWN HOW AND WHEN THE TIP BECAME SEPARATED FROM THE CATHETER. THE PATIENT'S CONDITION WAS STATED 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 14099284

    Patients

    Seq Age Sex Outcome Treatment
    1