BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014

    MDR report key: 1931595 · Received December 17, 2010

    Report

    Report Number
    2939204-2010-01157
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 8, 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 FOR CATHETER TRAPPED/STUCK IN LESION WERE FOUND IN THIS LOT. THE DEVICE WAS RETURNED FOR EVALUATION. THE GUIDEWIRE THAT WAS USED DURING THE PROCEDURE WAS ALSO RETURNED WITH THE CATHETER AS IT WAS STUCK IN THE DISTAL TIP SHEATH ASSEMBLY. VISUAL ANALYSIS OF THE CATHETER NOTED BLOODSTAIN INSIDE OF THE DISTAL TIP ASSEMBLY AND FLUID INSIDE THE TELESCOPE ASSEMBLY. NO FLUID WAS FOUND INSIDE THE HUB. NO KINK WAS OBSERVED IN THE SHEATH ASSEMBLY. ONE HUB WING WAS BENT AND THE GUIDEWIRE EXIT PORT WAS LIFTED 0.5MM LONG. THE GUIDEWIRE THAT WAS STUCK IN THE GUIDEWIRE DISTAL TIP SHEATH ASSEMBLY WAS REMOVED AND KINKS WERE OBSERVED ON THE GUIDEWIRE. THE RETURNED GUIDEWIRE OUTER DIAMETER WAS MEASURED TO BE 0.014", WHICH IS WITHIN THE RECOMMENDED SIZE PER DEVICE DIRECTIONS FOR USE. A TEST GUIDEWIRE (0.014") WAS INSERTED AND NO INDICATION OF RESISTANCE IN TRACKING THE GUIDEWIRE INTO THE CATHETER WAS NOTED. IMAGING CORE WINDUP IN THE TELESCOPE ASSEMBLY, WHICH CAN LEAD TO IMAGING LOSS, WAS ALSO OBSERVED BUT DID NOT CONTRIBUTE TO THE STUCK IN LESION. THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) WERE REVIEWED AND REVEALED THAT THE LABELING AND/OR DFU CONTAINS THESE WARNINGS AND PRECAUTIONS: 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." PRECAUTIONS: "NEVER ADVANCE THE DISTAL TIP OF THE IMAGING CATHETER NEAR THE VERY FLOPPY END OF THE GUIDEWIRE. THIS PART OF THE GUIDEWIRE WILL NOT ADEQUATELY SUPPORT THE CATHETER. A CATHETER ADVANCED TO THIS POSITION MAY NOT FOLLOW THE GUIDEWIRE WHEN IT IS RETRACTED AND CAUSE THE GUIDEWIRE TO BUCKLE INTO A LOOP WHICH THE CATHETER MAY DRAG ALONG THE INSIDE OF THE VESSEL AND CATCH ON THE GUIDE CATHETER TIP. IF THIS OCCURS, IT WILL BE NECESSARY TO REMOVE THE CATHETER ASSEMBLY, GUIDEWIRE AND THE GUIDE CATHETER TOGETHER. IF THE CATHETER IS ADVANCED TOO NEAR THE END OF THE GUIDEWIRE, ADVANCE THE GUIDEWIRE WHILE HOLDING THE IMAGING CATHETER STEADY. IF THIS FAILS, WITHDRAW THE CATHETER AND GUIDEWIRE TOGETHER." 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 REPORTED EVENT DESCRIPTION, DHR, SIMILAR COMPLAINTS REVIEWS AND OBSERVED DAMAGE TO THE EXIT PORT IT IS BELIEVED THAT PROCEDURAL/ANATOMICAL FACTORS (90% STENOSED LESION WITH CALCIFICATION IN MODERATE TORTUOSITY) ENCOUNTERED DURING THE PROCEDURE LIMITED THE PERFORMANCE OF THE DEVICE. A PROBABLE ROOT CAUSE OF OPERATIONAL CONTEXT HAS BEEN ASSIGNED TO THIS COMPLAINT FOR THE CATHETER TRAPPED/STUCK IN LESION.

    Description of Event or Problem · 1

    A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A 90% STENOSED AND MODERATELY TORTUOUS AND CALCIFIED LESION LOCATED IN THE MID-LEFT ANTERIOR DESCENDING ARTERY (LAD). AN INTRAVASCULAR ULTRASOUND (IVUS) IMAGING CATHETER WAS ADVANCED WITHOUT ISSUE AND USED TO IMAGE THE LESION. RESISTANCE WAS MET DURING WITHDRAWAL OF THE IVUS CATHETER. THE GUIDEWIRE EXIT PORT OF THE IVUS CATHETER AND THE GUIDEWIRE, WHICH HAD BENT, GOT STUCK IN THE LESION. THE IMAGING CORE OF THE CATHETER WAS REMOVED; THE IVUS CATHETER AND THE GUIDEWIRE WERE ADVANCED DISTALLY AND PULLED WITH TORQUING ALLOWING THE DEVICES TO BE REMOVED TOGETHER. THE PROCEDURE WAS CONTINUED WITH ANOTHER IVUS CATHETER. THE PATIENT WAS REPORTED TO BE IN "GOOD" CONDITION.

    Description of Event or Problem · 1

    A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A 90% STENOSED AND MODERATELY TORTUOUS AND CALCIFIED LESION LOCATED IN THE MID-LEFT ANTERIOR DESCENDING ARTERY (LAD). AN INTRAVASCULAR ULTRASOUND (IVUS) IMAGING CATHETER WAS ADVANCED WITHOUT ISSUE AND USED TO IMAGE THE LESION. RESISTANCE WAS MET DURING WITHDRAWAL OF THE IVUS CATHETER. THE GUIDEWIRE EXIT PORT OF THE IVUS CATHETER AND THE GUIDEWIRE, WHICH HAD BENT, GOT STUCK IN THE LESION. THE IMAGING CORE OF THE CATHETER WAS REMOVED; THE IVUS CATHETER AND THE GUIDEWIRE WERE ADVANCED DISTALLY AND PULLED WITH TORQUING ALLOWING THE DEVICES TO BE REMOVED TOGETHER. THE PROCEDURE WAS CONTINUED WITH ANOTHER IVUS CATHETER. THE PATIENT WAS REPORTED TO BE IN "GOOD" 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 13828465

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE CATHETER: MACH1, BSC| GUIDEWIRE: UNKNOWN