BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPO GUIDE CATHETER

    MDR report key: 1982369 · Received February 9, 2011

    Report

    Report Number
    2134265-2011-00440
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQO
    PMA / PMN Number
    K992142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. AN EXAMINATION OF THE DEVICE FOUND A SPLIT IN THE SHAFT 51.5CM FROM THE TIP. THE SPLIT EXTENDED ABOUT HALF WAY AROUND THE CIRCUMFERENCE OF THE SHAFT. MAGNIFIED INSPECTION REVEALED NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE. THERE WAS NO BRAID PROTRUDING FROM THE OUTER SURFACE OF THE SHAFT. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. 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)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIAGNOSTIC ANGIOGRAPHY PROCEDURE, CATHETER SHAFT DAMAGE WAS NOTED. THE PHYSICIAN WAS USING THIS 6F EXPO DIAGNOSTIC CATHETER IN MODERATELY TORTUOUS ANATOMY. THE CATHETER WAS USED TO DIAGNOSE BOTH THE LEFT AND RIGHT SYSTEM USING HAND INJECTION. WHEN THE CATHETER WAS REMOVED FROM THE PATIENT, A LINEAR SPLIT WAS NOTED MID-SHAFT. IT IS NOT THOUGHT THAT ANY FRAGMENTS DETACHED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIAGNOSTIC ANGIOGRAPHY PROCEDURE, CATHETER SHAFT DAMAGE WAS NOTED. THE PHYSICIAN WAS USING THIS 6F EXPO DIAGNOSTIC CATHETER IN MODERATELY TORTUOUS ANATOMY. THE CATHETER WAS USED TO DIAGNOSE BOTH THE LEFT AND RIGHT SYSTEM USING HAND INJECTION. WHEN THE CATHETER WAS REMOVED FROM THE PATIENT, A LINEAR SPLIT WAS NOTED MID-SHAFT. IT IS NOT THOUGHT THAT ANY FRAGMENTS DETACHED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPO GUIDE CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - MAPLE GROVE H749086413011 0050525119

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR