BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDERFX EMBOLIC PROTECTION DEVICE

    MDR report key: 3782093 · Received April 30, 2014

    Report

    Report Number
    2183870-2014-00081
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 1, 2014
    Manufacturer
    COVIDIEN
    Product Code
    NTE
    PMA / PMN Number
    K111010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 PLYMOUTH 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

    SPIDER WIRE SNAPPED DISTAL TO THE BASKET. THE FILTER WAS REMOVED UPON NORMAL RETRIEVAL. THE TIP OF SPIDER WIRE WAS LEFT IN THE PATIENT AFTER UNSUCCESSFUL REMOVAL VIA SNARE.

    Description of Event or Problem · 1

    THE SPIDER FX DEVICE WAS RECEIVED FOR EVALUATION WITH THE CAPTURE WIRE LOADED THROUGH THE RECOVERY SECTION OF THE DOUBLE-ENDED CATHETER THE FILTER ASSEMBLY WAS EXPOSED BEYOND THE CATHETER SHAFT. THE DISTAL WELD OF THE SPIDER FX PLATINUM/ TUNGSTEN COIL WAS SEPARATED FROM THE NITINOL CORE. THE TIP OF THE CORE EXHIBITED A FLAT FRACTURE FACE BUT THE NATURE OF A NITINOL FRACTURE WILL OBSCURE THE FRACTURE MODE (TENSILE/ TORSIONAL). THE LENGTH OF THE ATTACHED NITINOL CORE WAS 26MM FROM THE SPIRAL CONNECTOR. THE CATHETER WAS UNDAMAGED.

    Description of Event or Problem · 1

    THE SPIDER FX DEVICE WAS RECEIVED FOR EVALUATION WITH THE CAPTURE WIRE LOADED THROUGH THE RECOVERY SECTION OF THE DOUBLE-ENDED CATHETER THE FILTER ASSEMBLY WAS EXPOSED BEYOND THE CATHETER SHAFT. THE DISTAL WELD OF THE SPIDER FX PLATINUM/ TUNGSTEN COIL WAS SEPARATED FROM THE NITINOL CORE. THE TIP OF THE CORE EXHIBITED A FLAT FRACTURE FACE BUT THE NATURE OF A NITINOL FRACTURE WILL OBSCURE THE FRACTURE MODE (TENSILE/ TORSIONAL). THE LENGTH OF THE ATTACHED NITINOL CORE WAS 26MM FROM THE SPIRAL CONNECTOR. THE CATHETER WAS UNDAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260624 SPIDERFX EMBOLIC PROTECTION DEVICE TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE COVIDIEN SPD2-US-050-320 9826425

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention