BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014

    MDR report key: 1934848 · Received December 21, 2010

    Report

    Report Number
    2939204-2010-01144
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 BY EVENT DESCRIPTION WERE FOUND IN THE SAME BATCH. DURING INVESTIGATION FLUID WAS OBSERVED INSIDE OF THE DISTAL TIP AND TELESCOPE ASSEMBLIES. NO FLUID WAS FOUND INSIDE THE HUB. KINKS WERE OBSERVED IN THE SHEATH ASSEMBLY AND THE EXIT PORT WAS DAMAGED. A TEST GUIDEWIRE WAS INSERTED AND NO INDICATION OF RESISTANCE IN TRACKING THE GUIDEWIRE INTO THE CATHETER WAS NOTED. ADDITIONALLY, UNRELATED TO THE REPORTED EVENT THE TWO FLAPS OF HUB ROTATOR WERE NOTED TO BE DAMAGED, A DESIGN ISSUE. DURING IMAGE CHARACTERIZATION TESTING, NO IMAGE APPEARED IN THE SYSTEM DUE TO ELECTRICAL OPEN AT DISTAL THE CAUSE OF WHICH IS UNDETERMINABLE. THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) WERE REVIEWED AND REVEALED THAT THE LABELING AND/OR 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." 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 ANATOMICAL AND PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, THE CAUSE OF THE STUCK IN LESION HAS BEEN DETERMINED TO BE DUE TO OPERATIONAL CONTEXT. THE KINKS LIKELY ALSO OCCURRED DUE TO PROCEDURAL/ANATOMICAL FACTORS. THE RELATIONSHIP BETWEEN THE OBSERVED KINKS AND REPORTED ISSUE CANNOT BE DEFINITIVELY DETERMINED. THE MANUFACTURER WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY POTENTIAL TRENDS.

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), A BALLOON ANGIOPLASTY (POBA) WAS PERFORMED FOR AN IN STENT RESTENOSIS (ISR) LOCATED IN THE RIGHT CORONARY ARTERY DISTAL. THE PHYSICIAN ATTEMPTED TO IMAGE THE ARTERY USING AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER; HOWEVER, THE IMAGING CATHETER GOT STUCK IN THE RIGHT CORONARY ARTERY PROXIMAL (UNKNOWN WHETHER THE CATHETER CAUGHT THE STENT). IT IS BELIEVED THE DEVICE WAS REMOVED WITHOUT INCIDENT AS THE CASE WAS COMPLETED WITH ANOTHER DEVICE AND THE PATIENT CONDITION WAS REPORTED TO BE GOOD. AS IT APPEARS THE DEVICE WAS STUCK IN THE PATIENT'S ANATOMY WE ARE FILING THIS AS A SERIOUS INJURY.

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), A BALLOON ANGIOPLASTY (POBA) WAS PERFORMED FOR AN IN STENT RESTENOSIS (ISR) LOCATED IN THE RIGHT CORONARY ARTERY DISTAL. THE PHYSICIAN ATTEMPTED TO IMAGE THE ARTERY USING AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER; HOWEVER THE IMAGING CATHETER GOT STUCK IN THE RIGHT CORONARY ARTERY PROXIMAL (UNKNOWN WHETHER THE CATHETER CAUGHT THE STENT). IT IS BELIEVED THE DEVICE WAS REMOVED WITHOUT INCIDENT AS THE CASE WAS COMPLETED WITH ANOTHER DEVICE AND THE PATIENT CONDITION WAS REPORTED TO BE "GOOD". AS IT APPEARS THE DEVICE WAS STUCK IN THE PATIENT'S ANATOMY WE ARE FILING THIS AS A SERIOUS INJURY.

    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 0013832948

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SAPPHIRE BALLOON - UNKNOWN MANUFACTURER