BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014

    MDR report key: 1931816 · Received December 17, 2010

    Report

    Report Number
    2939204-2010-01126
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 25, 2010
    Report Date
    November 25, 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. THE CATHETER WAS RETURNED IN TWO PIECES. FIRST PIECE MEASURED 168.5 CM LONG AND THE SECOND PIECE, THE DISTAL TIP END, MEASURED 2.3 CM LONG. A CRACK WAS OBSERVED IN THE BROKEN DISTAL TIP ASSEMBLY 1.3 CM FROM DISTAL TIP END. VISUAL INSPECTION OF THE RETURNED CATHETER OBSERVED FLUID INSIDE OF THE DISTAL TIP ASSEMBLY AND TELESCOPE ASSEMBLY. NO FLUID WAS FOUND INSIDE THE HUB. A KINK WAS OBSERVED IN THE SHEATH ASSEMBLY AND ONE HUB WING WAS BENT, BOTH APPEAR TO BE UNRELATED TO THE TIP BREAK. OPERATIONAL CONTEXT IS THE LIKELY CAUSE FOR THE KINK. HANDLING DAMAGE IS THE LIKELY CAUSE OF THE BENT HUB WING. IMAGE CHARACTERIZATION TESTING WAS PERFORMED, A GOOD SQUARE IMAGE APPEARED IN THE SYSTEM AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. 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 (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. INADEQUATELY APPOSED STENTS, OVERLAPPING STENTS, AND/OR SMALL STENTED VESSELS WITH DISTAL ANGULATION MAY LEAD TO ENTRAPMENT OF THE CATHETER WITH THE STENT UPON RETRACTION. WHEN RETRACTING THE CATHETER, ENSURE THAT THE SHORT RAIL DISTAL TIP IS PARALLEL TO THE GUIDEWIRE. SEPARATION OR BENDING OF THE GUIDEWIRE MAY RESULT IN KINKING OF THE GUIDEWIRE, DAMAGE TO THE CATHETER DISTAL TIP, AND/OR VESSEL INJURY. THE LOOPED GUIDEWIRE OR DAMAGED TIP MAY CATCH ON THE STENT STRUT RESULTING IN ENTRAPMENT. 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

    DURING PREPARATION OF THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER OUTSIDE THE PATIENT FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, THE IVUS CATHETER WAS FLUSHED AND LOADED ONTO A GUIDE WIRE. WHEN ATTEMPTING TO INSERT THE IVUS CATHETER INTO A Y-CONNECTOR OUTSIDE THE PATIENT, THE PHYSICIAN NOTICED THAT APPROXIMATELY 2.5 CM OF THE DISTAL TIP OF THE IVUS CATHETER HAD DETACHED. THE PHYSICIAN REPORTED NO RESISTANCE WAS FELT. THE PROCEDURE WAS COMPLETED WITH A NEW IVUS CATHETER AND THE PATIENT STATUS WAS REPORTED AS 'GOOD".

    Description of Event or Problem · 1

    DURING PREPARATION OF THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER OUTSIDE THE PATIENT FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, THE IVUS CATHETER WAS FLUSHED AND LOADED ONTO A GUIDE WIRE. WHEN ATTEMPTING TO INSERT THE IVUS CATHETER INTO A Y-CONNECTOR OUTSIDE THE PATIENT, THE PHYSICIAN NOTICED THAT APPROXIMATELY 2.5 CM OF THE DISTAL TIP OF THE IVUS CATHETER HAD DETACHED. THE PHYSICIAN REPORTED NO RESISTANCE WAS FELT. THE PROCEDURE WAS COMPLETED WITH A NEW IVUS CATHETER AND THE PATIENT STATUS WAS REPORTED AS "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 0013280986

    Patients

    Seq Age Sex Outcome Treatment
    1 Y-CONNECTOR: UNKNOWN MANUFACTURER| GUIDE WIRE: UNKNOWN MANUFACTURER