BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS SR PRO CORONARY IMAGING CATHETER, MODEL 38942

    MDR report key: 1880444 · Received October 22, 2010

    Report

    Report Number
    2939204-2010-01012
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED BY THE FACILITY THEREFORE NO DEVICE ANALYSIS COULD BE PERFORMED. THE LOT NUMBER OF THE DEVICE IS UNKNOWN. A SHIP HISTORY WAS PERFORMED TO IDENTIFY THE LOT NUMBER OF THE DEVICE LIKELY UTILIZED IN THIS PROCEDURE. REVIEW OF THE SHIP HISTORY IDENTIFIED FOUR POTENTIAL LOTS. THE DEVICE HISTORY RECORD (DHR) AND SIMILAR COMPLAINTS WERE REVIEWED FOR EACH OF THE POTENTIAL LOTS AND NO ISSUES OR DISCREPANCIES WERE FOUND. THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) 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. 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. ALTHOUGH THE PRODUCT WAS NOT RETURNED FOR ANALYSIS IT APPEARS TO HAVE MET SPECIFICATIONS BASED ON THE DHR REVIEW. THE ROOT CAUSE OF THIS COMPLAINT HAS BEEN DETERMINED TO BE DUE TO OPERATIONAL CONTEXT BASED ON THE DETAILS OF THE EVENT AND THE ANATOMICAL (VESSEL ANGULATION) AND PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4) - NEW CODE REQUEST HAS BEEN SUBMITTED FOR STUCK IN STENT.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2010-04721. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE TO TREAT A LESION IN THE MID LAD (LEFT ANTERIOR DESCENDING) AN INTRAVASCULAR IMAGING (IVUS) CATHETER BECAME STUCK IN A STENT. THE LESION WAS PREDILATED, A STENT WAS PLACED AND THEN POST DILATED. IVUS WAS PERFORMED. WHILE PASSING THE IVUS CATHETER THROUGH THE STENT, THE DISTAL END OF THE CATHETER CAUGHT ON THE PROXIMAL EDGE OF THE STENT AS IT WAS ADVANCED AROUND A FAIRLY SIGNIFICANT BEND IN THE VESSEL CREATING A SMALL AREA OF MALPOSITION (APPROXIMATELY 1.5MM). THE PHYSICIAN INDICATED THAT THE REASON THIS OCCURRED WAS BECAUSE OF ANGULATION WITHIN THE VESSEL AT A LARGE SEPTAL BRANCH. THERE WAS NO ACTUAL FAULT WITH THE IVUS CATHETER ITSELF. ADDITIONAL POST DILATION WAS PERFORMED WITH A 4MM BALLOON WITH A GOOD FINAL RESULT. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2010-04721. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE TO TREAT A LESION IN THE MID LAD (LEFT ANTERIOR DESCENDING) AN INTRAVASCULAR IMAGING (IVUS) CATHETER BECAME STUCK IN A STENT. THE LESION WAS PREDILATED, A STENT WAS PLACED AND THEN POST DILATED. IVUS WAS PERFORMED. WHILE PASSING THE IVUS CATHETER THROUGH THE STENT, THE DISTAL END OF THE CATHETER CAUGHT ON THE PROXIMAL EDGE OF THE STENT AS IT WAS ADVANCED AROUND A FAIRLY SIGNIFICANT BEND IN THE VESSEL CREATING A SMALL AREA OF MALAPPOSITION (APPROXIMATELY 1.5MM). THE PHYSICIAN INDICATED THAT THE REASON THIS OCCURRED WAS BECAUSE OF ANGULATION WITHIN THE VESSEL AT A LARGE SEPTAL BRANCH. THERE WAS NO ACTUAL FAULT WITH THE IVUS CATHETER ITSELF. ADDITIONAL POST DILATION WAS PERFORMED WITH A 4MM BALLOON WITH A GOOD FINAL RESULT. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS SR PRO CORONARY IMAGING CATHETER, MODEL 38942 CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT H749389420

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR GUIDE CATHETER, UNKNOWN| GUIDEWIRE, UNKNOWN| STUDY STENT, BSC