BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHIOCE GUIDEWIRE

    MDR report key: 1893039 · Received November 8, 2010

    Report

    Report Number
    2134265-2010-05110
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K970244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED EVIDENCE THAT THE DISTAL TIP HAD BEEN PRE-SHAPED. KINKS WERE PRESENT AT 1, 1.5, 2, 56, 158 AND 170CM PROXIMAL TO THE DISTAL TIP. DIMENSIONAL MEASUREMENTS WERE WITHIN SPECIFICATIONS. NO OTHER DAMAGE OR INCONSISTENCIES WERE NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE STENT DELIVERY SYSTEM BECAME STUCK ON THE GUIDE WIRE. THE CHOICE PT GUIDE WIRE WAS PLACED IN A LESION IN AN UNSPECIFIED VESSEL. A NON BSC STENT WAS LOADED ONTO THE WIRE AND BECAME STUCK WHILE ADVANCING; THE STENT WAS UNABLE TO ADVANCE FURTHER THAN THE GUIDE CATHETER. AFTER A FEW UNSUCCESSFUL ATTEMPTS TO REMOVE THE STENT DELIVERY SYSTEM, THE DEVICES WERE REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CHOICE PT GUIDE WIRE AND A DIFFERENT NON BSC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE STENT DELIVERY SYSTEM BECAME STUCK ON THE GUIDE WIRE. THE CHOICE PT GUIDE WIRE WAS PLACED IN A LESION IN AN UNSPECIFIED VESSEL. A NON BSC STENT WAS LOADED ONTO THE WIRE AND BECAME STUCK WHILE ADVANCING; THE STENT WAS UNABLE TO ADVANCE FURTHER THAN THE GUIDE CATHETER. AFTER A FEW UNSUCCESSFUL ATTEMPTS TO REMOVE THE STENT DELIVERY SYSTEM, THE DEVICES WERE REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CHOICE PT GUIDE WIRE AND A DIFFERENT NON BSC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHIOCE GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA H7491216101J1

    Patients

    Seq Age Sex Outcome Treatment
    1 XIENCE V STENT