BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPULSE GUIDE CATHETERS

    MDR report key: 2010340 · Received March 8, 2011

    Report

    Report Number
    2134265-2011-00629
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQO
    PMA / PMN Number
    K992142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: AN EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE SHAFT WAS KINKED 5CM AND 7.5CM FROM THE TIP. THE OUTER AND INNER DIAMETERS OF THE SHAFT WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATION. A .038" GUIDE WIRE WAS ADVANCED THROUGH THE WIRE LUMEN WITH NO UNUSUAL RESISTANCE ENCOUNTERED. NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE KINKS 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

    AGE AT TIME OF EVENT: (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VENTRICULOGRAM DIAGNOSTIC PROCEDURE, CATHETER REMOVAL DIFFICULTIES OCCURRED. THE PHYSICIAN ADVANCED THE 5FR IMPULSE GUIDE CATHETER AND PROBED THE RIGHT AND LEFT CORONARY ARTERIES FOR CORONARY ARTERY DISEASE. NEXT, THE PHYSICIAN ATTEMPTED TO CROSS THE AORTIC VALVE, HOWEVER, A KINK IN THE IMPULSE CATHETER WAS NOTED 3CM PROXIMAL TO THE PIGTAIL LOOP. THE PHYSICIAN ATTEMPTED TO REMOVE THE IMPULSE CATHETER, HOWEVER, REMOVAL DIFFICULTIES WERE ENCOUNTERED. A NON-BSC GUIDE WIRE WAS ADVANCED TO STRAIGHTEN THE IMPULSE CATHETER, AND THE IMPULSE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. A NON-BSC CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VENTRICULOGRAM DIAGNOSTIC PROCEDURE, CATHETER REMOVAL DIFFICULTIES OCCURRED. THE PHYSICIAN ADVANCED THE 5FR IMPULSE GUIDE CATHETER AND PROBED THE RIGHT AND LEFT CORONARY ARTERIES FOR CORONARY ARTERY DISEASE. NEXT, THE PHYSICIAN ATTEMPTED TO CROSS THE AORTIC VALVE, HOWEVER, A KINK IN THE IMPULSE CATHETER WAS NOTED 3CM PROXIMAL TO THE PIGTAIL LOOP. THE PHYSICIAN ATTEMPTED TO REMOVE THE IMPULSE CATHETER, HOWEVER, REMOVAL DIFFICULTIES WERE ENCOUNTERED. A NON-BSC GUIDE WIRE WAS ADVANCED TO STRAIGHTEN THE IMPULSE CATHETER, AND THE IMPULSE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. A NON-BSC CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPULSE GUIDE CATHETERS CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - MAPLE GROVE H749163913001

    Patients

    Seq Age Sex Outcome Treatment
    1