BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014

    MDR report key: 2094260 · Received May 18, 2011

    Report

    Report Number
    2939204-2011-00279
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 21, 2011
    Report Date
    May 1, 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) 2011 (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. A SIMILAR COMPLAINT REVIEW WAS PERFORMED AND NO LOT SPECIFIC ISSUES WERE FOUND. VISUAL INSPECTION REVEALED 2.5CM OF THE DISTAL TIP WAS DETACHED WHEN RECEIVED. ONE HUB WING WAS BENT AND APPEARS TO BE UNRELATED TO THE TIP BREAK. HANDLING DAMAGE IS THE LIKELY CAUSE OF THE BENT HUB WING. IMAGE CHARACTERIZATION TESTING REVEALED A GOOD SQUARE IMAGE APPEARED IN THE SYSTEM AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. 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) 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. -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 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.

    Description of Event or Problem · 1

    UPON INSPECTION OF THE RETURNED INTRAVASCULAR ULTRASOUND (IVUS) IMAGING CATHETER, FOR A REPORTED ISSUE WITH THE IMAGE, THE MANUFACTURER OBSERVED THE TIP OF THE CATHETER HAD DETACHED. THE USER HAD NOT INDICATED THEY HAD EXPERIENCED OR OBSERVED ANY BREAKAGE OF THE IVUS CATHETER. FOLLOW UP DETERMINED THAT THE PHYSICIAN AND A CO-MEDICAL STAFF WERE NOT AWARE THAT THE TIP SEPARATION OCCURRED. THEY INDICATED, IT DID NOT OCCUR IN THE CATH LAB; IT IS UNKNOWN WHEN AND HOW THE DETACHMENT OCCURRED.

    Description of Event or Problem · 1

    UPON INSPECTION OF THE RETURNED INTRAVASCULAR ULTRASOUND (IVUS) IMAGING CATHETER, FOR A REPORTED ISSUE WITH THE IMAGE, THE MANUFACTURER OBSERVED THE TIP OF THE CATHETER HAD DETACHED. THE USER HAD NOT INDICATED THEY HAD EXPERIENCED OR OBSERVED ANY BREAKAGE OF THE IVUS CATHETER. FOLLOW UP DETERMINED THAT THE PHYSICIAN AND A CO-MEDICAL STAFF WERE NOT AWARE THAT THE TIP SEPARATION OCCURRED. THEY INDICATED, IT DID NOT OCCUR IN THE CATH LAB; IT IS UNKNOWN WHEN AND HOW THE DETACHMENT OCCURRED.

    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 13738155

    Patients

    Seq Age Sex Outcome Treatment
    1