BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014

    MDR report key: 2003075 · Received February 28, 2011

    Report

    Report Number
    2939204-2011-00102
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 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

    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 REVEALED THE DISTAL TIP ASSEMBLY WAS BROKEN OFF (APPROXIMATELY 2.8 CM) AND WAS NOT RECEIVED. FLUID WAS OBSERVED INSIDE OF THE TELESCOPE AND DISTAL TIP ASSEMBLY. NO FLUID WAS FOUND INSIDE THE HUB AND NO KINK WAS OBSERVED IN THE SHEATH ASSEMBLY. UNRELATED TO THE TIP BREAK, THE IMAGING CORE WAS OBSERVED TO BE WOUND UP IN THE HUB (A DESIGN ISSUE) AND WAS BROKEN OFF FROM THE TELESCOPE. ADDITIONALLY, THE HUB O-RING WAS OBSERVED TO HAVE MOVED FROM ITS PROPER LOCATION. 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. LOWER LEVELS OF OXIDATION WERE FOUND AT THE SURFACE OF AND THROUGHOUT THE IMAGING WINDOW SAMPLE THAT WAS CUT FROM THE RETURNED COMPLAINT DEVICE AT APPROXIMATELY 7 CM FROM THE LAP JOINT THE DEVICE LABELING AND DIRECTIONS FOR USE 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." "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 INDICATIONS 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. CUSTOMER NOTIFICATION HAS BEEN DISTRIBUTED TO (B)(6) CUSTOMERS AND SENT TO THE PMDA. FDA REPORT OF CORRECTION AND REMOVAL WAS FILED (B)(4) 2001 ((B)(4)).

    Description of Event or Problem · 1

    A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON A 90% STENOSED, MODERATELY TORTUOUS LESION WITHOUT CALCIFICATION LOCATED IN THE MIDDLE RIGHT CORONARY ARTERY (RCA). WHILE INSERTING AN INTRAVASCULAR ULTRASOUND (IVUS) IMAGING CATHETER INTO THE PATIENT THE PHYSICIAN HEARD A "SNAP" SOUND, THERE WAS NO RESISTANCE DURING ADVANCEMENT. THE IMAGE WAS NOT AFFECTED, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY COMPLETE IMAGING THE LESION AND THE IMAGING CATHETER WAS REMOVED WITH NO ISSUE. THE LESION WAS DILATED WITH A BALLOON CATHETER. THE PHYSICIAN WAS OUTSIDE THE PATIENT'S ANATOMY ATTEMPTING TO LOAD THE IMAGING CATHETER ONTO THE GUIDEWIRE, IN PREPARATION TO IMAGE THE LESION AGAIN, WHEN THE TIP OF THE IMAGING CATHETER FRACTURED AND DETACHED FROM THE CATHETER BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER IVUS. THE PATIENT IS REPORTED TO BE IN "GOOD" CONDITION.

    Description of Event or Problem · 1

    A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON A 90% STENOSED, MODERATELY TORTUOUS LESION WITHOUT CALCIFICATION LOCATED IN THE MIDDLE RIGHT CORONARY ARTERY (RCA). WHILE INSERTING AN INTRAVASCULAR ULTRASOUND (IVUS) IMAGING CATHETER INTO THE PATIENT THE PHYSICIAN HEARD A "SNAP" SOUND, THERE WAS NO RESISTANCE DURING ADVANCEMENT. THE IMAGE WAS NOT AFFECTED, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY COMPLETE IMAGING THE LESION AND THE IMAGING CATHETER WAS REMOVED WITH NO ISSUE. THE LESION WAS DILATED WITH A BALLOON CATHETER. THE PHYSICIAN WAS OUTSIDE THE PATIENT'S ANATOMY ATTEMPTING TO LOAD THE IMAGING CATHETER ONTO THE GUIDEWIRE, IN PREPARATION TO IMAGE THE LESION AGAIN, WHEN THE TIP OF THE IMAGING CATHETER FRACTURED AND DETACHED FROM THE CATHETER BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER IVUS. THE PATIENT IS 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 13721415

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATHETER: SHEATHLESS| BALLOON CATHETER: SIGNET| GUIDEWIRE: RINATO