BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014

    MDR report key: 2069888 · Received April 26, 2011

    Report

    Report Number
    2939204-2011-00216
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    December 14, 2010
    Report Date
    April 5, 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

    CUSTOMER NOTIFICATION HAS BEEN DISTRIBUTED TO JAPANESE CUSTOMERS AND SENT TO THE PMDA. FDA REPORT OF CORRECTION AND REMOVAL WAS FILED (B)(4) 2001 (REFERENCE # 9912058-3/3/14/2011-0001-C). ADD'L MFR. NARRATIVE: 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 THIS LOT. VISUAL INSPECTION OF THE RETURNED CATHETER OBSERVED FLUID INSIDE THE TELESCOPE AND DISTAL TIP ASSEMBLY. NO FLUID WAS FOUND INSIDE THE HUB AND NO KINK WAS OBSERVED IN THE SHEATH ASSEMBLY. THE TWO FLAPS OF THE HUB ROTATOR WERE DAMAGED; HOWEVER, THE UNIT WAS ABLE TO CONNECT INTO MDU SYSTEM PROPERLY. FLUID WAS LEAKING FROM THE SHEATH WHEN THE CATHETER WAS FLUSHED DURING TESTING. DURING IMAGE CHARACTERIZATION TESTING, A GOOD SQUARE IMAGE APPEARED IN THE SYSTEM AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. AFTER THE IMAGING TEST, IT WAS FOUND THAT THE DISTAL TIP BROKE OFF IN THE TEST MODEL. THE CATHETER BROKE IN TWO LOCATIONS WITH PIECES MEASURING 2.6CM AND 4.3CM AND THE REMAINING PORTION MEASURED 163.5CM LONG. 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) 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 WAS ASSIGNED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS SENT OUT FOR ADDITIONAL TESTING.

    Description of Event or Problem · 1

    AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER RETURNED FOR DEVICE ANALYSIS OF A NON-REPORTABLE ISSUE WAS PROCESSING NORMALLY. IMAGING TEST WAS PERFORMED THE CATHETER SHOWED GOOD IMAGE BUT IT WAS NOTICED AFTER THE TEST THAT THE TIP OF THE IVUS HAD DETACHED AND REMAINED IN THE TEST MODEL. THE DEVICE WAS NOT EXCESSIVELY MANIPULATED OR HANDLED.

    Description of Event or Problem · 1

    AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER RETURNED FOR DEVICE ANALYSIS OF A NON-REPORTABLE ISSUE WAS PROCESSING NORMALLY. IMAGING TEST WAS PERFORMED THE CATHETER SHOWED GOOD IMAGE BUT IT WAS NOTICED AFTER THE TEST THAT THE TIP OF THE IVUS HAD DETACHED AND REMAINED IN THE TEST MODEL. THE DEVICE WAS NOT EXCESSIVELY MANIPULATED OR HANDLED.

    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 13598335

    Patients

    Seq Age Sex Outcome Treatment
    1