BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F/G ATLANTIS SR PRO2

    MDR report key: 1040258 · Received May 7, 2008

    Report

    Report Number
    2939204-2008-00166
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THE REPORTED BATCH AND NO SIGNIFICANT INFO RELEVANT TO THE REPORTED EVENT WAS FOUND. NO SIMILAR COMPLAINTS WERE FOUND IN THE SAME BATCH. DURING INVESTIGATION, IT WAS OBSERVED THAT COMPLAINT SAMPLE HAD BEEN RETURNED WITHOUT THE IMAGING CORE; THEREFORE, FUNCTIONAL TEST COULD NOT BE PERFORMED. THE HUB, TELESCOPE AND SHEATH ASSEMBLY WERE RECEIVED. THE GUIDEWIRE THAT WAS USED DURING PROCEDURE WAS NOT RETURNED. A TEST GUIDEWIRE WAS INSERTED AND NO INDICATION OF RESISTANCE IN TRACKING THE GUIDEWIRE INTO THE CATHETER WAS NOTED. BLOODSTAIN WAS OBSERVED INSIDE OF THE DISTAL TIP ASSEMBLY. NO FLUID WAS FOUND INSIDE THE HUB. NO KINK WAS OBSERVED IN THE SHEATH ASSEMBLY. THE GUIDEWIRE EXIT PORT WAS LIFTED 1.0 MM LONG. THE GUIDEWIRE EXIT PORT DAMAGE AND LACK OF IMAGING CORE ARE ALL TYPICAL OF EXCESSIVE MANIPULATION AND INTERVENTION METHOD UTILIZED BY THE PHYSICIAN IN THE ATTEMPT TO FREE THE DEVICE. THE ATLANTIS SR PRO2 PRODUCT LABELS CONTAIN DIMENSIONS OF THE CATHETER TIP AS WELL AS THE FOLLOWING WARNINGS IN THE DFU: "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. IF RESISTANCE IS MET UPON WITHDRAWAL OF THE CATHETER, VERIFY RESISTANCE USING FLUOROSCOPY, THEN REMOVE THE ENTIRE SYSTEM SIMULTANEOUSLY. 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 CONDITION OF THE DEVICE, AND THE ANATOMICAL AND PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, THE CAUSE OF THIS EVENT IS BEING CLASSIFIED AS OPERATIONAL CONTEXT. THE MFR WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER BECAME STUCK ON A STENT. THE LESION BEING TREATED WAS 90% STENOSED WITHOUT CALCIFICATION IN A SEVERELY TORTUOUS AREA OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A GUIDE CATHETER AND GUIDEWIRE WERE USED TO CROSS THE LESION FOLLOWED BY DEPLOYMENT OF TWO STENTS IN THE PROXIMAL AND MID LAD. IVUS CATHETER WAS USED TO CONFIRM STENT DEPLOYMENT AND UPON REMOVAL OF THE IVUS CATHETER, IT BECAME STUCK AT THE EDGE OF ON OF THE STENTS. THE PHYSICIAN SEPARATED THE CATHETER AT THE MALE/FEMALE LUER CONNECTORS AND REMOVED THE IMAGING CORE. A GUIDEWIRE WAS INSERTED INTO THE SHEATH ASSEMBLY TO PUSH THE CATHETER OFF THE STENT; HOWEVER, THE RELEASE ATTEMPT WAS UNSUCCESSFUL. THE PHYSICIAN THEN INSERTED AND INFLATED A BALLOON CATHETER NEAR THE CAUGHT CATHETER; ALLOWING RELEASE AND REMOVAL OF THE SHEATH ASSEMBLY. THE PT WAS REPORTED TO BE IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F/G ATLANTIS SR PRO2 CORONARY IMAGING CATHETER DQO BOSTON SCIENTIFIC CORP. 39014 11508972

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK-GUIDECATHETER| UNK-GUIDEWIRE| MEDTRONIC-DRIVER STENTS