BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE GPS SELF-EXPANDING PERIPHERAL STENT SYSTEM

    MDR report key: 3840516 · Received May 30, 2014

    Report

    Report Number
    2183870-2014-00120
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 2, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K050725
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN (B)(6). THE PHYSICIAN REPORTED THAT THE STENT COULD NOT BE DEPLOYED. HOWEVER, INVESTIGATION OF THE RETURNED DEVICE ON (B)(6) 2014 FOUND THAT THE PROTEGE GPS WAS RETURNED IN FULL DEPLOYMENT PROFILE: DEPLOYMENT PADDLES WERE IN CLOSE PROXIMITY TO EACH OTHER, THE OUTER SHEATH WAS PULLED BACKED EXPOSING THE RETAINER, AND NO STENT RETURNED. THE LOCATION OF THE STENT IS NOT KNOWN AT THIS TIME. ADDITIONALLY, SALINE AND BIOLOGICAL RESIDUE WAS NOTED IN/ON THE STOPCOCK VALVE AND TUBE. THE DISTAL TIP EXHIBITS GROOVE DAMAGE ON ITS PROXIMAL END. THE DISTAL MARKER BAND WAS LOOSE ON THE GUIDEWIRE LUMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319344 PROTEGE GPS SELF-EXPANDING PERIPHERAL STENT SYSTEM CATHETER, BILIARY, DIAGNOSTI FGE COVIDIEN SERP65-09-30-80 9670907

    Patients

    Seq Age Sex Outcome Treatment
    1 Other