BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NANOCROSS

    MDR report key: 4121808 · Received September 26, 2014

    Report

    Report Number
    2183870-2014-00242
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 29, 2014
    Manufacturer
    PLYMOUTH
    Product Code
    DQY
    PMA / PMN Number
    K090849
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL 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

    EVALUATION SUMMARY:THE CATHETER EXHIBITED A TWIST IMMEDIATELY DISTAL TO THE PROXIMAL BALLOON BOND. THE BALLOON MATERIAL WAS WRAPPED TIGHT OVER THE INNER SHAFT AT THE PROXIMAL CONE. THE BALLOON BODY EXHIBITED A TWIST IN THE PROXIMAL HALF. THE BALLOON EXHIBITED A PUNCTURE.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN (B)(6). THE PHYSICIAN COULD NOT DEFLATE THE NANOCROSS BALLOON AFTER INFLATION. AS A RESULT, THE PHYSICIAN PERFORMED A DIRECT PUNCTURE ON THE BALLOON TO REMOVE IT. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601725 NANOCROSS CATHETER, PERCUTANEOUS, DQY PLYMOUTH AB14W020210150 9865349

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention