BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND EX 014/205 FLOPPY

    MDR report key: 3342150 · Received September 11, 2013

    Report

    Report Number
    3008853977-2013-00333
    Event Type
    Injury
    Date Received
    September 11, 2013
    Date of Event
    August 8, 2013
    Report Date
    August 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K934122
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE NOT AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATIONS NONCONFORMANCE OR MISUSE. THERE IS ALSO NO INDICATION THAT THE SUBJECT DEVICE MALFUNCTIONED. HOWEVER, VESSEL PERFORATION AND STROKE ARE KNOWN RISKS ASSOCIATED WITH SUCH PROCEDURES AND NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE STROKES. THE PHYSICIAN BELIEVES THAT THE STROKES WERE DUE TO THE GUIDEWIRE PERFORATING A VESSEL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IN HER LATE FIFTIES PRESENTED WITH AN UNRUPTURED ANEURYSM. THE PATIENT UNDERWENT TREATMENT OF THE ANEURYSM. POST PROCEDURE, A VESSEL PERFORATION WAS NOTED. MULTIPLE STROKES OCCURRED ON THE CONTRALATERAL SIDE OVERNIGHT AND INTO THE NEXT DAY. NO ACTION WAS TAKEN AS MAJOR INFARCTION WAS IDENTIFIED IN SEVERAL AREAS. IT IS UNKNOWN WHEN THE STROKES RESOLVED. THE PATIENT IS CURRENTLY ON VENTILATION DUE TO ACUTE RESPIRATORY DISTRESS SYSTEM WHICH IS UNRELATED TO THE EVENT. THE PHYSICIAN BELIEVES THAT DIFFICULTY TORQUING THE GUIDEWIRE LET TO THE REPORTED VESSEL PERFORATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IN HER LATE FIFTIES PRESENTED WITH AN UNRUPTURED ANEURYSM. THE PATIENT UNDERWENT TREATMENT OF THE ANEURYSM. POST PROCEDURE, A VESSEL PERFORATION WAS NOTED. MULTIPLE STROKES OCCURRED ON THE CONTRALATERAL SIDE OVERNIGHT AND INTO THE NEXT DAY. NO ACTION WAS TAKEN AS MAJOR INFARCTION WAS IDENTIFIED IN SEVERAL AREAS. IT IS UNKNOWN WHEN THE STROKES RESOLVED. THE PATIENT IS CURRENTLY ON VENTILATION DUE TO ACUTE RESPIRATORY DISTRESS SYSTEM WHICH IS UNRELATED TO THE EVENT. THE PHYSICIAN BELIEVES THAT DIFFICULTY TORQUING THE GUIDEWIRE LET TO THE REPORTED VESSEL PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455897 TRANSEND EX 014/205 FLOPPY WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other