BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAILBLAZER SUPPORT CATHETER

    MDR report key: 3955781 · Received July 24, 2014

    Report

    Report Number
    2183870-2014-00188
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    COVIDIEN
    Product Code
    DQY
    PMA / PMN Number
    K092299
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. TWO ANGIOGRAPHIC IMAGES WERE RECEIVED SHOWING THE TRAILBLAZER IN THE VESSEL. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE TRAILBLAZER CATHETER WAS RECEIVED FOR EVALUATION WITHOUT THE SECTION OF THE CATHETER CONTAINING THE MARKER BANDS . THE DISTAL END OF THE FRACTURED CATHETER EXHIBITED LONGITUDINAL STRETCHING/ NECKING. THE LENGTH OF THE CATHETER SEGMENT WAS 132.8CM FROM THE DISTAL EDGE OF THE STRAIN RELIEF. THE NOMINAL DIMENSION FOR THE CATHETER TO THE PROXIMAL MARKER BAND IS APPROXIMATELY 105CM. THIS WOULD SUGGEST THAT THE CATHETER WAS SUBJECTED TO TENSILE FORCES EXCEEDING THE MATERIALS YIELD STRENGTH. THERE WAS ALSO A KINK 5.1CM FROM THE FRACTURE FACE.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN (B)(6). WHILE WITHDRAWING THE TRAILBLAZER FROM THE PATIENT, THE PHYSICIAN FELT GREAT RESISTANCE WHEN IT PASSED THROUGH THE LESION POSITION. LOOKING AT ANGIO IMAGES THE TIP OF THE TRAILBLAZER WAS FOUND TO BE BROKEN AND LEFT IN THE PATIENT. THE BROKEN TIP OF THE TRAILBLAZER WAS JAILED UP WITH A STENT IN THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434245 TRAILBLAZER SUPPORT CATHETER CATHETER, PERCUTANEOUS DQY COVIDIEN SC-018-135 9846810

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention