BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDERFX EMBOLIC PROTECTION DEVICE

    MDR report key: 3881891 · Received June 18, 2014

    Report

    Report Number
    2183870-2014-00139
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    COVIDIEN
    Product Code
    NTE
    PMA / PMN Number
    K111010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS 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.

    Additional Manufacturer Narrative · 1

    THIS 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.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE DISTAL TIP OF THE SPIDERFX WIRE DETACHED. THE TIP OF THE WIRE BECAME LODGED IN A COLLATERAL OF THE POPLITEAL ARTERY. THE PHYSICIAN STATED THAT HE ATTEMPTED TO REMOVE THE PIECE WITH A SNARE BUT WAS UNSUCCESSFUL. THE PHYSICIAN DECIDED TO LEAVE IT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357547 SPIDERFX EMBOLIC PROTECTION DEVICE TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE COVIDIEN SPD2-US-070-320 9745165

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention