BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014

    MDR report key: 1962618 · Received January 18, 2011

    Report

    Report Number
    2939204-2010-01185
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 27, 2010
    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 WERE FOUND IN THE LOT. THE CATHETER WAS RETURNED IN TWO PIECES. FIRST PIECE, THE DISTAL TIP END, MEASURED 2.5CM LONG AND THE REST OF THE CATHETER MEASURED 168.3CM LONG. VISUAL INSPECTION OF THE RETURNED CATHETER OBSERVED FLUID INSIDE OF THE TELESCOPE AND DISTAL TIP ASSEMBLY. NO FLUID WAS FOUND INSIDE THE HUB AND NO KINK WAS OBSERVED IN THE SHEATH ASSEMBLY. DURING IMAGE CHARACTERIZATION TESTING, A GOOD SQUARE IMAGE APPEARED IN THE SYSTEM AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. THE DEVICE WAS EVALUATED USING SCANNING ELECTRON MICROSCOPY (SEM) AND FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) WITH OXIDATION INDEX. BASED ON THE INFORMATION GATHERED FROM BOTH EVALUATION METHODS, HIGH LEVELS OF OXIDATION AT THE SURFACE AND THROUGHOUT THE TESTED SAMPLE WERE NOTED. THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) REVEALED 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.

    Description of Event or Problem · 1

    PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED IN A 99% STENOSED LESION WITH SEVERE CALCIFICATION AND MODERATE TORTUOSITY IN THE OSTIUM OF THE RIGHT CORONARY ARTERY (RCA) PROXIMAL. THE LESION WAS ABLATED. THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS PREPPED WITHOUT INCIDENT AND SUCCESSFULLY USED FOR PRE-IMAGING OF THE LESION WITH NO RESISTANCE FELT DURING USE. THE IVUS CATHETER WAS REMOVED FROM THE PATIENT AND A STENT IMPLANTED IN THE LESION. WHEN ATTEMPTING TO LOAD THE IVUS CATHETER ONTO THE GUIDEWIRE OUTSIDE THE PATIENT IN PREPARATION TO USE THE IVUS CATHETER AGAIN, THIS TIME TO VIEW STENT PLACEMENT, THE PHYSICIAN NOTED THE TIP OF THE IVUS CATHETER BECAME DETACHED NEAR THE GUIDEWIRE EXIT PORT. THE PROCEDURE WAS COMPLETED WITH A NEW IVUS CATHETER. THE PATIENT STATUS IS REPORTED AS "FINE'.

    Description of Event or Problem · 1

    PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED IN A 99% STENOSED LESION WITH SEVERE CALCIFICATION AND MODERATE TORTUOSITY IN THE OSTIUM OF THE RIGHT CORONARY ARTERY (RCA) PROXIMAL. THE LESION WAS ABLATED. THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS PREPPED WITHOUT INCIDENT AND SUCCESSFULLY USED FOR PRE-IMAGING OF THE LESION WITH NO RESISTANCE FELT DURING USE. THE IVUS CATHETER WAS REMOVED FROM THE PATIENT AND A STENT IMPLANTED IN THE LESION. WHEN ATTEMPTING TO LOAD THE IVUS CATHETER ONTO THE GUIDEWIRE OUTSIDE THE PATIENT IN PREPARATION TO USE THE IVUS CATHETER AGAIN, THIS TIME TO VIEW STENT PLACEMENT, THE PHYSICIAN NOTED THE TIP OF THE IVUS CATHETER BECAME DETACHED NEAR THE GUIDEWIRE EXIT PORT. THE PROCEDURE WAS COMPLETED WITH A NEW IVUS CATHETER. THE PATIENT STATUS IS REPORTED AS "FINE".

    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 13581353

    Patients

    Seq Age Sex Outcome Treatment
    1 FIELDER, ROTAWIRE FLOPPY GUIDEWIRE