BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014

    MDR report key: 2002970 · Received February 28, 2011

    Report

    Report Number
    2939204-2011-00079
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 9, 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

    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 LOT. THE RETURNED DEVICE HAD APPROXIMATELY 2.5CM OF THE DISTAL TIP OF THE CATHETER BROKEN OFF WHEN RECEIVED. DURING VISUAL ANALYSIS, BLOODSTAIN WAS OBSERVED INSIDE OF THE DISTAL TIP AND IMAGING WINDOW ASSEMBLY AND FLUID WAS OBSERVED INSIDE THE TELESCOPE ASSEMBLY. NO FLUID WAS FOUND INSIDE THE HUB. NO KINK WAS OBSERVED IN THE SHEATH ASSEMBLY. IMAGE CHARACTERIZATION TESTING RESULTED IN NO IMAGE APPEARING IN THE SYSTEM DUE TO ELECTRICAL LOSS AT THE DISTAL END OF THE CATHETER, WHICH IS NOT RELATED TO THE TIP DETACHMENT. 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) 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. 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." 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 FRAGILE 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 HAS BEEN ASSIGNED. (B)(4).

    Description of Event or Problem · 1

    A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT STENOSIS IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS PREPARED PER THE DIRECTIONS FOR USE, NO ANOMALIES WERE NOTED. A STENT WAS IMPLANTED AND THE IVUS CATHETER WAS USED. AFTER THE PHYSICIAN REMOVED THE IVUS CATHETER FROM THE PATIENT, HE LIGHTLY WIPED THE TIP OF THE CATHETER WITH WET GAUZE, AT WHICH POINT THE TIP DETACHED FROM THE CATHETER. THERE WAS NO DIFFICULTY OR RESISTANCE DURING ADVANCING, CROSSING, AND WITHDRAWING THE CATHETER. THE PATIENT CONDITION IS REPORTED TO BE "GOOD".

    Description of Event or Problem · 1

    A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT STENOSIS IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS PREPARED PER THE DIRECTIONS FOR USE, NO ANOMALIES WERE NOTED. A STENT WAS IMPLANTED AND THE IVUS CATHETER WAS USED. AFTER THE PHYSICIAN REMOVED THE IVUS CATHETER FROM THE PATIENT, HE LIGHTLY WIPED THE TIP OF THE CATHETER WITH WET GAUZE, AT WHICH POINT THE TIP DETACHED FROM THE CATHETER. THERE WAS NO DIFFICULTY OR RESISTANCE DURING ADVANCING, CROSSING, AND WITHDRAWING THE CATHETER. THE PATIENT CONDITION IS REPORTED TO BE '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 13754407

    Patients

    Seq Age Sex Outcome Treatment
    1 RUNTHROUGH GUIDEWIRE (TERUMO)| 7F INTRODUCER SHEATH (TERUMO)| HEARTRAIL GUIDE CATHETER (TERUMO)| DRIVER SPRINT CORONARY STENT (MEDTRONIC)| EVEREST INFLATION DEVICE (MEDTRONIC)