BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014

    MDR report key: 2083654 · Received May 10, 2011

    Report

    Report Number
    2939204-2011-00260
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    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

    CUSTOMER NOTIFICATION HAS BEEN DISTRIBUTED TO (B)(6) CUSTOMERS AND SENT TO THE (B)(6). FDA REPORT OF CORRECTION AND REMOVAL WAS FILED (B)(6) 2011 (REFERENCE # (B)(4)). 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. INSPECTION OF THE RETURNED CATHETER REVEALED 2.5 CM OF THE TIP WAS DETACHED, THE MALE/FEMALE LUER CONNECTION WAS DETACHED AND THE IMAGING CORE WAS OUTSIDE OF THE SHEATH ASSEMBLY. VISUAL INSPECTION OF THE RETURNED CATHETER OBSERVED A KINK IN THE SHEATH ASSEMBLY AND ONE HUB WING WAS BENT, BOTH APPEAR TO BE UNRELATED TO THE TIP BREAK. OPERATIONAL CONTEXT IS THE LIKELY CAUSE FOR THE KINK. HANDLING DAMAGE IS THE LIKELY CAUSE OF THE BENT HUB WING. A KINK WAS ALSO OBSERVED ON THE DETACHED TIP LIKELY A RESULT OF THE TIP BEING SNARED DURING RETRIEVAL. A GREEN SUBSTANCE OBSERVED ON THE RJ11 PINS OF THE HUB ASSEMBLY HAS BEEN OBSERVED PREVIOUSLY ON RETURNED DEVICES. IT IS PRIMARILY ORGANIC AND IS LIKELY CORROSION FROM OXIDATION OF THE RJ11 METALS CAUSED BY USE OF HEPARINIZED SALINE. CONTINUITY TESTING SHOWED NO ISSUES INDICATING THE RESIDUE DID NOT CAUSE OR CONTRIBUTE TO DEVICE ISSUES. IMAGING CORE WIND UP IN THE TELESCOPE ASSEMBLY WAS OBSERVED. WINDUP, 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

    INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS USED TO IMAGE POST STENT PLACEMENT IN A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) MIDDLE AND FIRST DIAGONAL. THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE CATHETER, RESISTANCE WAS FELT WHILE ATTEMPTING TO CROSS THE LESION. THE PHYSICIAN PULLED THE CATHETER WITHDRAWING IT FROM THE PATIENT. UPON REMOVAL, THE PHYSICIAN OBSERVED THAT THE TIP OF THE CATHETER (INCLUDING THE RO MARKER) HAD BECOME DETACHED AND REMAINED IN THE LAD. THE SEPARATED TIP WAS SUCCESSFULLY RETRIEVED WITH A GOOSENECK SNARE. THE PATIENT IS REPORTED TO BE IN "STABLE" CONDITION.

    Description of Event or Problem · 1

    IN A PERCUTANEOUS CORONARY INTERVENTION (PCI) AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS USED TO IMAGE POST STENT PLACEMENT IN A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) MIDDLE AND FIRST DIAGONAL. THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE CATHETER, RESISTANCE WAS FELT WHILE ATTEMPTING TO CROSS THE LESION. THE PHYSICIAN PULLED THE CATHETER WITHDRAWING IT FROM THE PATIENT. UPON REMOVAL THE PHYSICIAN OBSERVED THAT THE TIP OF THE CATHETER (INCLUDING THE RO MARKER) HAD BECOME DETACHED AND REMAINED IN THE LAD. THE SEPARATED TIP WAS SUCCESSFULLY RETRIEVED WITH A GOOSENECK SNARE. THE PATIENT IS REPORTED TO BE IN "STABLE" 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 13615973

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STENT: VISION 3.5X12MMMANUFACTURER: ABBOTT| STENT: VISION 2.5X12MMMANUFACTURER: ABBOTT