BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERHAWK LX-M

    MDR report key: 5219381 · Received November 12, 2015

    Report

    Report Number
    2183870-2015-00449
    Event Type
    Malfunction
    Date Received
    November 12, 2015
    Date of Event
    April 29, 2014
    Report Date
    April 30, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MCW
    PMA / PMN Number
    K053460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4). (B)(6).

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN MADE MULTIPLE PASSES. DIFFICULTY WAS NOTED WHEN TRYING TO ADVANCE IN A CERTAIN PLANE. THE PHYSICIAN THEN EXPERIENCED DIFFICULTY TURNING THE CUTTER OFF SO THE DEVICE WAS REMOVED. DIFFICULTY WAS EXPERIENCED WHEN TRYING TO CLEAN THE DEVICE. THE TISSUE PLUNGER WAS FORCED FORWARD BUT THE PHYSICIAN FELT THIS MAY HAVE DAMAGED THE DEVICE SO A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY IS REPORTED. EVALUATION SUMMARY: THE SILVERHAWK WAS RECEIVED FOR EVALUATION. THE DISTAL TIP ASSEMBLY EXHIBITED A RUPTURE OF THE HOUSING PET, COIL, TECOTHANE WALL. THE RUPTURE CONTAINED CALCIFIC TISSUE RESIDUE THAT HAD ERUPTED THROUGH THE TIP ASSEMBLY COMPONENTS. THE PLUNGER COMPONENT WAS LOCATED IMMEDIATELY DISTAL TO THE COLLECTED TISSUE. SOME OF THE ERUPTED TISSUE WAS PRIED OFF THE ASSEMBLY REVEALING LASER-CUT COIL STRANDS AND POLYMER FILM. THE HOUSING'S PLATINUM-IRIDIUM LASER-CUT COIL SECTION EXHIBITED SEVERAL DEFORMATIONS INCLUDING SOME CUTTING AT THE DISTAL EDGE OF THE HOUSING WINDOW AND CUTTING AND DELAMINATION OF THE HOUSING'S LASER-CUT COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750298 SILVERHAWK LX-M CATHETER, PERIPHERAL, ATHERECTOMY MCW COVIDIEN P4055 9828046

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention