BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANOCROSS ELITE 0.014" OVER-THE-WIRE PTA BALLOON DILATATION CATHETER

    MDR report key: 3981521 · Received August 5, 2014

    Report

    Report Number
    2183870-2014-00194
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    COVIDIEN
    Product Code
    LIT
    PMA / PMN Number
    K141118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE BALLOON WOULD NOT DEFLATE AFTER ONLY ONE INFLATION. SEVERAL ATTEMPTS WERE MADE TO DEFLATE THE BALLOON SUCCESSFULLY. BALLOON HAD TO BE REMOVED WHILE STILL INFLATED. THE VESSEL THAT WAS BEING TREATED WAS TOTALLY OCCLUDED.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE CATHETER EXHIBITED A TWIST IMMEDIATELY DISTAL TO THE PROXIMAL BALLOON BOND. AS A RESULT, THE BALLOON MATERIAL WAS WRAPPED TIGHT OVER THE INNER SHAFT AT THE PROXIMAL CONE. THE CATHETER WAS PRESSURIZED TO RATED BURST PRESSURE (14ATM) AND ALLOWED TO STABILIZE. A VACUUM WAS PULLED AND THE BALLOON FULLY DEFLATED IN 21 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456523 NANOCROSS ELITE 0.014" OVER-THE-WIRE PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COVIDIEN AB14W020210150 9882048

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other