BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE¿ WIREGUIDED

    MDR report key: 3002340 · Received March 13, 2013

    Report

    Report Number
    3005099803-2013-01082
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    January 13, 2013
    Report Date
    February 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE EVENT REVEALED BY THE INVESTIGATION OF EXIT MARKER BUNCHED. THE 510K NUMBER IS K112994. INVESTIGATION RESULTS: VISUAL ANALYSIS OF THE RETURNED DEVICE SHOWED THAT THERE WERE NO KINKS ON THE CATHETER; HOWEVER THE DISTAL TIP OF THE GUIDE WIRE WAS KINKED. THE EXIT MARKER WAS ALSO FOUND TO BE BUNCHED. FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE BALLOON WAS RELAXED AND DEFLATED; AND THEREFORE COULD NOT BE ADVANCED DOWN THE ENDOSCOPE. THE CONDITION OF THE RETURNED DEVICE IS CONSISTENT WITH FORCE APPLIED DURING INSERTION AND WITHDRAWAL THROUGH THE SCOPE. THESE FAILURES LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE PERFORMANCE OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING DILATATION PROCEDURE IN THE ESOPHAGUS ON (B)(6) 2013. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE CATHETER OF THE BALLOON BECAME STUCK INSIDE THE ENDOSCOPE; SO FORCE WAS APPLIED AND THE DEVICE WAS REMOVED FROM THE SCOPE. IT WAS ALSO REPORTED THAT THE CATHETER WAS KINKED. NO OTHER DAMAGE WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. INVESTIGATION RESULTS REVEALED THE EXIT MARKER WAS BUNCHED UP, THEREFORE THIS IS NOW AN MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105243 CRE¿ WIREGUIDED BALLOON DILATOR KNQ BOSTON SCIENTIFIC - CORK M00558700 14844019

    Patients

    Seq Age Sex Outcome Treatment
    1