BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME? RX 44

    MDR report key: 3110823 · Received May 14, 2013

    Report

    Report Number
    3005099803-2013-03903
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    February 20, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESPONSE TO AN FDA REQUEST LETTER FOR THIS MEDWATCH REPORT IS ATTACHED.

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE EVENT: CATHETER TORN. VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THERE WAS A PRONOUNCED KINK IN THE WORKING LENGTH OF THE DEVICE AND THE DISTAL PIERCE HOLE WAS MELTED AND TORN 7 MM. THE CUTTING WIRE LENGTH WAS MEASURED AND FOUND TO MEET SPECIFICATIONS. FUNCTIONAL EVALUATION FOUND THAT THE DEVICE FAILED TO BOW FAR ENOUGH TO MEET SPECIFICATION WHEN TESTED BOTH OUTSIDE AND INSIDE THE DUODENOSCOPE. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WAS OPERATIONAL CONTEXT, SINCE MANIPULATION/USE OF THE DEVICE DURING THE PROCEDURE COULD HAVE CAUSED THE FAILURE FOUND. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THE DEVICE WAS POSITIONED INSIDE THE PATIENT FOR SPHINCTEROTOMY, THE TOME COULD NOT BE BOWED. NO VISIBLE DAMAGE TO THE TOME WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING: CATHETER TORN.

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THE DEVICE WAS POSITIONED INSIDE THE PATIENT FOR SPHINCTEROTOMY, THE TOME COULD NOT BE BOWED. NO VISIBLE DAMAGE TO THE TOME WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING: CATHETER TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213305 HYDRATOME? RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00583040 15677454

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR