BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND EX 014/205 PLATINUM

    MDR report key: 5368343 · Received January 14, 2016

    Report

    Report Number
    3008853977-2016-00013
    Event Type
    Injury
    Date Received
    January 14, 2016
    Date of Event
    November 1, 2015
    Report Date
    December 17, 2015
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K971254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, FUNCTIONAL TESTING AS WELL AS PHYSICAL ANALYSIS CANNOT BE PERFORMED. ALTHOUGH THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE BATCH REMAINS UNKNOWN, THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MEET SPECIFICATIONS UPON RELEASE. INFORMATION FROM THE EVENT INDICATED THAT THE GUIDEWIRE MIGRATED INTO THE PREVIOUS CHOROIDAL ARTERY AND BECAME STUCK. THE CAUSE FOR THE GUIDEWIRE MIGRATION TO THE CHOROIDAL ARTERY COULD NOT BE DEFINITELY DETERMINED. THE CAUSE OF THE UN-RETRIEVED DEVICE FRAGMENT IS RELATED TO HANDLING SINCE IT WAS REPORTED THAT THE DEVICE WAS CUT INTENTIONALLY SINCE IT BECAME STUCK INSIDE THE ANATOMY. PER THE DEVICE DFU: "VESSEL TRAUMA MAY RESULT FROM THE IMPROPER USE OF THIS DEVICE. FOLLOW THE INSTRUCTIONS FOR USE CAREFULLY. WHEN THE GUIDEWIRE IS IN THE BODY, IT SHOULD BE MANIPULATED ONLY UNDER FLUOROSCOPY. DO NOT ATTEMPT TO MOVE THE WIRE WITHOUT OBSERVING THE RESULTANT TIP RESPONSE..." AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS WAS ASSIGNED TO THE STROKE AND CASCADING EFFECTS IN RELATION TO STROKE-RELATED COMPLICATIONS AS THESE ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURE AND ARE NOTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU).

    Additional Manufacturer Narrative · 1

    EVENT DATE: THE EXACT DATE OF THE ADVERSE EVENT IS UNKNOWN. (B)(4). DEVICE REMAINS IN THE PATIENT'S BODY.

    Description of Event or Problem · 1

    THE JOURNAL OF NEUROENDOVASCULAR THERAPY (JNET 1-P2-1) PUBLISHED THAT A PATIENT WAS UNDERGOING COIL EMBOLIZATION FOR A UN-RUPTURE ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY (A-COM). IT WAS REPORTED THAT AS THE GUIDEWIRE WAS ADVANCED TO THE C2 PART OF THE INTRA CAROTID ARTERY AND THE MICROCATHETER ADVANCED OVER IT, THE GUIDEWIRE MIGRATED TO THE PREVIOUSLY TRACKED CAROTID ARTERY AND BECAME STUCK. UNSUCCESSFUL ATTEMPTS WERE PERFORMED TO REMOVE THE GUIDEWIRE. THE GUIDE CATHETER AND MICROCATHETER WERE REMOVED. THE PHYSICIAN PERFORMED A CRANIOTOMY AND CONFIRMED THAT THE TIP OF THE GUIDEWIRE AT THE CRANIOTOMY AREA. ULTIMATELY, THE PHYSICIAN DECIDED TO CUT THE GUIDEWIRE AT THE ACCESS SITE AND LEFT IN THE PATIENT'S BODY. AFTER THE PROCEDURE, CEREBRAL INFARCTION OCCURRED AT THE CHOROIDAL ARTERY WHICH RESULTED IN RIGHT PARALYSIS, RIGHT PARESTHESIA, SENSORY APHASIA, RIGHT BLINDNESS AS SEQUELAE. SIX MONTHS POST PROCEDURE, THE PATIENT WAS TRANSFERRED TO A CARE FACILITY AND WALKED ASSISTED BY A CANE. SEVEN YEARS AFTER THE INITIAL PROCEDURE, THE PATIENT EXPERIENCED DISORIENTATION, RIGHT PARALYSIS, AND WALKS ASSISTED BY A CANE. THE PATIENT'S PROCEDURE ACCESS SITE HAD NO PROBLEMS. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE JOURNAL OF NEUROENDOVASCULAR THERAPY (JNET 1-P2-1) PUBLISHED THAT A PATIENT WAS UNDERGOING COIL EMBOLIZATION FOR A UN-RUPTURE ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY (A-COM). IT WAS REPORTED THAT AS THE GUIDEWIRE WAS ADVANCED TO THE C2 PART OF THE INTRA CAROTID ARTERY AND THE MICROCATHETER ADVANCED OVER IT, THE GUIDEWIRE MIGRATED TO THE PREVIOUSLY TRACKED CAROTID ARTERY AND BECAME STUCK. UNSUCCESSFUL ATTEMPTS WERE PERFORMED TO REMOVE THE GUIDEWIRE. THE GUIDE CATHETER AND MICROCATHETER WERE REMOVED. THE PHYSICIAN PERFORMED A CRANIOTOMY AND CONFIRMED THAT THE TIP OF THE GUIDEWIRE AT THE CRANIOTOMY AREA. ULTIMATELY, THE PHYSICIAN DECIDED TO CUT THE GUIDEWIRE AT THE ACCESS SITE AND LEFT IN THE PATIENT'S BODY. AFTER THE PROCEDURE, CEREBRAL INFARCTION OCCURRED AT THE CHOROIDAL ARTERY WHICH RESULTED IN RIGHT PARALYSIS, RIGHT PARESTHESIA, SENSORY APHASIA, RIGHT BLINDNESS AS SEQUELAE. SIX MONTHS POST PROCEDURE, THE PATIENT WAS TRANSFERRED TO A CARE FACILITY AND WALKED ASSISTED BY A CANE. SEVEN YEARS AFTER THE INITIAL PROCEDURE, THE PATIENT EXPERIENCED DISORIENTATION, RIGHT PARALYSIS, AND WALKS ASSISTED BY A CANE. THE PATIENT'S PROCEDURE ACCESS SITE HAD NO PROBLEMS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27443 TRANSEND EX 014/205 PLATINUM WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R