BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANSONNENBERG¿ SUMP

    MDR report key: 3021423 · Received March 26, 2013

    Report

    Report Number
    2134265-2013-01835
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FFA
    PMA / PMN Number
    K944290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED A GUIDE WIRE WHICH WAS SEVERELY KINKED ALONG THE ENTIRE BODY WITH THE COIL UNRAVELED, ELONGATED AND SEPARATED INTO TWO SECTIONS. THE DEVICE CATHETER WAS NOT RETURNED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION 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 LIVER PUNCTURE WITH DRAINAGE TREATMENT PROCEDURE, DIFFICULTY IN CATHETER REMOVAL AND DETACHMENT OCCURRED. THE PHYSICIAN WAS UNABLE TO REMOVE THE GUIDE. THE GUIDE WAS REMOVED STRECH AND THERE WAS A BREAK WITH THE SHEATH. THE DRAIN STAYED IN PLACE AND THERE WAS NO DETACHED COMPONENT REMAINING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LIVER PUNCTURE WITH DRAINAGE TREATMENT PROCEDURE, DIFFICULTY IN CATHETER REMOVAL AND DETACHMENT OCCURRED. THE PHYSICIAN WAS UNABLE TO REMOVE THE GUIDE. THE GUIDE WAS REMOVED STRETCH AND THERE WAS A BREAK WITH THE SHEATH. THE DRAIN STAYED IN PLACE AND THERE WAS NO DETACHED COMPONENT REMAINING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123843 VANSONNENBERG¿ SUMP TUBE, DRAINAGE, SUPRAPUBIC FFA BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001273070 0015238498

    Patients

    Seq Age Sex Outcome Treatment
    1