BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F/G ATLANTIS SR PRO2

    MDR report key: 1161628 · Received September 15, 2008

    Report

    Report Number
    2939204-2008-00373
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 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 (DHR) WAS PERFORMED ON THE BATCH AND NO ISSUES OR DISCREPANCIES WERE FOUND, THE BATCH MET ALL REQUIRED SPECIFICATIONS. NO SIMILAR COMPLAINTS WERE FOUND IN THE SAME LOT. PHYSICAL ANALYSIS WAS NOT POSSIBLE DUE TO DEVICE DISPOSAL. 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, HISTORICAL INVESTIGATIONS, CURRENT CONTROLS DURING MANUFACTURING PROCESS IN ORDER TO ASSURE INTEGRITY, INVESTIGATION TREND ANALYSIS, AND INFORMATION AVAILABLE AT THIS MOMENT; THERE IS NO INDICATION THAT THE RELEASED DEVICE, LABELING OR PACKAGING FAILED TO MEET ITS MANUFACTURER SPECIFICATIONS. THIS TYPE OF EVENT IS LIKELY CAUSED BY ANATOMICAL AND PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE; THEREFORE, THE CAUSE OF THIS EVENT IS BEING CLASSIFIED AS OPERATIONAL CONTEXT. THE MANUFACTURER 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 IMAGING CATHETER BECAME STUCK WITH A STENT. THE LESION BEING TREATED WAS 75% STENOSED AND CALCIFIED WITH MODERATE TORTUOSITY IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A GUIDECATHETER AND GUIDEWIRE WERE USED TO ACCESS THE LESION. THE LESION WAS PRE-DILATED WITH A BALLOON CATHETER, AND PHYSICIAN CONFIRMED MINIMAL LUMEN DIAMETER (MLD) WITH ANGIOGRAPHY. AFTER MLD CONFIRMATION, A STENT WAS DEPLOYED. AN INTRAVASCULAR ULTRA SOUND (IVUS) CATHETER WAS TRACKED THROUGH THE STENTED AREA WITHOUT DIFFICULTIES, AND IVUS WAS PERFORMED. DURING IMAGING IVUS CATHETER CONFIRMED INCOMPLETE APPOSITION OF THE STENT. UPON WITHDRAWAL OF THE IVUS CATHETER FROM THE TREATED AREA, THE CATHETER BECAME STUCK WITH THE STENT. PHYSICIAN MADE UNSUCCESSFUL ATTEMPTS TO RELEASE THE CATHETER; THE STENT DEFORMED AND THE IVUS CATHETER AND DEPLOYED STENT WERE REMOVED SURGICALLY. PATIENT WAS REPORTED TO BE IN STABLE 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 11787298

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R ABBOT .014 BMW GUIDEWIRE| MEDTRONIC - MICRO DRIVER 2.25MM CORONARY STENT| TERUMO CORP 6F JL4 HEARTRAIL GUIDECATHETER| TERUMO CORP 1.5MM RYUJIN BALLOON CATHETER