BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014

    MDR report key: 1933445 · Received December 20, 2010

    Report

    Report Number
    2939204-2010-01148
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 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 TIP DETACHED/SEPARATED WERE FOUND IN THIS LOT. DURING VISUAL ANALYSIS, BLOODSTAIN WAS OBSERVED INSIDE OF THE DISTAL TIP ASSEMBLY AND FLUID WAS OBSERVED INSIDE THE TELESCOPE ASSEMBLY. NO FLUID WAS FOUND INSIDE THE HUB. NO KINK WAS OBSERVED IN THE SHEATH ASSEMBLY. THE CATHETER WAS RECEIVED IN TWO PIECES; THE DISTAL TIP ASSEMBLY WAS BROKEN OFF (2.5CM LONG) AND MISSING, THE REMAINDER OF THE CATHETER MEASURED 168.7CM LONG. DURING IMAGE CHARACTERIZATION TESTING, A GOOD IMAGE APPEARED IN THE SYSTEM. THE FRACTURE LOCATION OF THE DISTAL TIP SECTION WAS ANALYZED USING SEM (SCANNING ELECTRON MICROSCOPY). BASED ON RESULTS OF THE SEM ANALYSIS, THIS BREAK IS CLEAN AND ABRUPT WITH NO SIGNS OF ELONGATION. THIS BREAK IS CONSISTENT WITH PREVIOUS FAILURES OF THIS NATURE THAT HAD A HIGHER LEVEL OF CATHETER OXIDATION AND BRITTLENESS. THE DEVICE LABELING AND DIRECTIONS FOR USE (B)(4) 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. TORTUOUSITY OF ANATOMY, CALCIFICATION, AND A HIGH PERCENT OF STENOSIS ARE ALL POTENTIAL CAUSES OF DIFFICULTY ADVANCING, INABILITY TO CROSS A LESION AND/OR RESISTANCE ENCOUNTERED DURING THE PROCEDURE. THE FRAGILE TIP DETACHMENT FAILURE 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 WAS ASSIGNED.

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), PERFORMED VIA RADIAL APPROACH, THE PHYSICIAN ATTEMPTED TO IMAGE THE LESION WITH AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. THE 90% STENOSED AND SEVERELY CALCIFIED LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA) PROXIMAL AND THE OSTIUM OF THE RCA WAS TORTUOUS. THE LESION WAS ATTEMPTED TO BE PRE DILATED WITH A BALLOON, HOWEVER THE BALLOON DID NOT EXPAND WELL. THE PHYSICIAN FELT RESISTANCE WHILE TRYING TO ADVANCE THE CATHETER INTO THE LESION AND WAS UNABLE TO CROSS THE LESION. DURING THE ATTEMPT TO WITHDRAW THE CATHETER FROM THE PATIENT, NO RESISTANCE WAS FELT, HOWEVER, THE TIP SEPARATED; THIS WAS CONFIRMED WITH RADIOGRAPHY IMAGE. THE DETACHED TIP REMAINED IN THE PATIENT AT THE LESION LOCATION. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE TIP, HOWEVER THE TIP MIGRATED DURING THE PROCESS. THE PHYSICIAN THEN PERFORMED A CORONARY ANGIOGRAPHY (CAG) AND THE TIP WAS LOCATED IN THE LEFT ANTEBRACHIAL REGION. THE PHYSICIAN USED FORCEPS TO SUCCESSFULLY REMOVE THE TIP FROM THE RADIAL. THE PATIENT WAS REPORTED TO BE IN "GOOD" CONDITION.

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), PERFORMED VIA RADIAL APPROACH, THE PHYSICIAN ATTEMPTED TO IMAGE THE LESION WITH AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. THE 90% STENOSED AND SEVERELY CALCIFIED LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA) PROXIMAL AND THE OSTIUM OF THE RCA WAS TORTUOUS. THE LESION WAS ATTEMPTED TO BE PRE DILATED WITH A BALLOON, HOWEVER, THE BALLOON DID NOT EXPAND WELL. THE PHYSICIAN FELT RESISTANCE WHILE TRYING TO ADVANCE THE CATHETER INTO THE LESION AND WAS UNABLE TO CROSS THE LESION. DURING THE ATTEMPT TO WITHDRAW THE CATHETER FROM THE PATIENT, NO RESISTANCE WAS FELT, HOWEVER, THE TIP SEPARATED; THIS WAS CONFIRMED WITH RADIOGRAPHY IMAGE. THE DETACHED TIP REMAINED IN THE PATIENT AT THE LESION LOCATION. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE TIP, HOWEVER, THE TIP MIGRATED DURING THE PROCESS. THE PHYSICIAN THEN PERFORMED A CORONARY ANGIOGRAPHY (CAG) AND THE TIP WAS LOCATED IN THE LEFT ANTEBRACHIAL REGION. THE PHYSICIAN USED FORCEPS TO SUCCESSFULLY REMOVE THE TIP FROM THE RADIAL. 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 13170868

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BALLOON - NC VOYAGER 2.5X18MM| GC - UNKNOWN MACH| GW - UNKNOWN