BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOICE (TM) PT

    MDR report key: 2102532 · Received May 25, 2011

    Report

    Report Number
    2134265-2011-01904
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K970244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RECEIVED IN TWO PIECES. AN EXAMINATION OF THE COMPLAINT DEVICE FOUND THAT PROXIMAL PIECE WAS 54CM IN LENGTH. THE DISTAL PIECE WAS 128CM IN LENGTH. THERE IS A KINK LOCATED 53.3CM FROM THE PROXIMAL END OF THE PROXIMAL PIECE. ALL OUTER DIAMETER MEASUREMENTS TAKEN WERE FOUND TO MEET SPECIFICATION. SEM ANALYSIS OF THE WIRE FOUND THAT THE FRACTURE SITE EXHIBITED EVIDENCE OF COMPRESSION AND TENSION CHARACTERISTIC OF A BENDING EVENT. ELONGATED DIMPLE RUPTURES WERE OBSERVED ON THE FRACTURE SURFACE TYPICAL OF AN OVERLOAD. THE FRACTURE WAS DUE TO A BENDING OVERLOAD. NO MATERIAL ANOMALIES WERE FOUND. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY TREATMENT PROCEDURE, A GUIDE WIRE BREAK OCCURRED. THIS 182CM CHOICE PT GUIDE WIRE WAS ADVANCED INTO THE LEFT ANTERIOR DESCENDING (LAD) AND THEN INTO THE "QUESTIONABLE" LEFT MAIN (LM) WITHOUT ISSUES. ANOTHER MANUFACTURERS' IVUS CATHETER WAS THEN LOADED ONTO THE GUIDE WIRE WHEN THE PROXIMAL END OF THE GUIDE WIRE KINKED AND BROKE. THIS OCCURRED OUTSIDE THE PATIENT. THE REMAINING WIRE WAS REMOVED FROM THE PATIENT AND A NEW CHOICE PT GUIDE WIRE WAS INSERTED. THE SAME IVUS CATHETER WAS THEN USED AND THE PROCEDURE WAS COMPLETED WITH THE IMPLANTATION OF A 5.00X12MM VERIFLEX STENT IN THE LM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY TREATMENT PROCEDURE, A GUIDE WIRE BREAK OCCURRED. THIS 182CM CHOICE PT GUIDE WIRE WAS ADVANCED INTO THE LEFT ANTERIOR DESCENDING (LAD) AND THEN INTO THE "QUESTIONABLE" LEFT MAIN (LM) WITHOUT ISSUES. ANOTHER MANUFACTURERS' IVUS CATHETER WAS THEN LOADED ONTO THE GUIDE WIRE WHEN THE PROXIMAL END OF THE GUIDE WIRE KINKED AND BROKE. THIS OCCURRED OUTSIDE THE PATIENT. THE REMAINING WIRE WAS REMOVED FROM THE PATIENT AND A NEW CHOICE PT GUIDE WIRE WAS INSERTED. THE SAME IVUS CATHETER WAS THEN USED AND THE PROCEDURE WAS COMPLETED WITH THE IMPLANTATION OF A 5.00X12MM VERIFLEX STENT IN THE LM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOICE (TM) PT WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA H7491216101J1

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR VOLCANO IVUS CATHETER