BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERCROSS .035" OTW PTA DILATATION CATHETER

    MDR report key: 4091420 · Received September 16, 2014

    Report

    Report Number
    2183870-2014-00231
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    COVIDIEN
    Product Code
    LIT
    PMA / PMN Number
    K110319
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL 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

    THE PHYSICIAN DEPLOYED A 10X40X120 STENT IN THE LEFT COMMON FEMORAL ARTERY VIA THE LEFT BRACHIAL ARTERY ACCESS OVER A .035" GLIDEWIRE AND 6F SHEATH. THIS LEFT COMMON FEMORAL DISEASED AREA WAS ALSO THE LOCATION OF A DISTAL ANASTOMOSIS FROM A BILATERAL AORTO-ILIAC BYPASS PROCEDURE. THE PHYSICIAN APPRECIATED A RESIDUAL DEFECT IN THE STENT AND CHOSE TO UTILIZE AN EVERCROSS 8X40X135 BALLOON TO POST DILATE. AT 14ATM THE BALLOON BURST. THE PHYSICIAN COULD NOT RETRIEVE THE BALLOON AFTER MULTIPLE FAILED ATTEMPTS. THE PHYSICIAN THEN CONTACTED A SURGEON WHO WAS ABLE TO SUCCESSFULLY REMOVE THE BALLOON. PATIENT WAS STABLE POST-OP.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: ALL COMPONENTS OF THE EVERCROSS DILATATION CATHETER DISTAL OF THE Y-MANIFOLD AND STRAIN-RELIEF WERE RETURNED AND ACCOUNTED FOR. THE CATHETER EXHIBITED NUMEROUS KINKS; THE PROXIMAL END OF THE INNER LUMEN EXHIBITED ACCORDION FOLDING; THE PROXIMAL BALLOON MATERIAL EXHIBITED BOTH LONGITUDINAL AND RADIAL TEARING; AND THE DISTAL BALLOON MATERIAL EXHIBITED RADIAL TEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571325 EVERCROSS .035" OTW PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COVIDIEN AB35W08040135 9604397

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention .035" TERUMO GLIDEWIRE| 6F 90CM COOK SHEATH