BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NANOCROSS .014" OTW PTA DILATATION CATHETER

    MDR report key: 3913957 · Received July 3, 2014

    Report

    Report Number
    2183870-2014-00166
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    COVIDIEN
    Product Code
    LIT
    PMA / PMN Number
    K141118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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

    INITIALLY, THE NANOCROSS BALLOON WOULD NOT DEFLATE. AFTER SEVERAL ATTEMPTS, THE BALLOON SLOWLY DEFLATED TO THE POINT IT COULD BE REMOVED FROM THE PATIENT. TRIED WITH THE INFLATION DEVICE TO DEFLATE BALLOON, THEN TRIED WITH AN EMPTY SYRINGE. THE PHYSICIAN THEN TRIED TO INFLATE THE BALLOON SLIGHTLY MORE THEN DEFLATE. THE PHYSICIAN WAS ABLE TO GET IT TO DEFLATE BY EMPTYING MOST OF CONTRAST FROM THE INFLATION DEVICE AND DEFLATING. THE NANOCROSS BALLOON DEFLATED ENOUGH TO PULL BACK TO SHEATH OVER 4-5 MINUTES.

    Description of Event or Problem · 1

    RESULT OF THE EVALUATION ON THE RETURNED DEVICE: THE CATHETER EXHIBITED A TWIST IMMEDIATELY DISTAL TO THE PROXIMAL BALLOON BOND. A GLYCERIN/ WATER SOLUTION WAS MADE THAT APPROXIMATES THE VISCOSITY OF A 50/50 CONTRAST/ SALINE MIXTURE. AN INFLATION DEVICE WAS LOADED WITH THE SOLUTION AND WAS ATTACHED TO THE CATHETER'S INFLATION LUMEN. THE SYSTEM WAS PRESSURIZED TO 7ATM (NOMINAL PRESSURE), THE BALLOON STILL EXHIBITED A RESIDUAL TWIST AT THE PROXIMAL CONE. THE BALLOON WAS ALLOWED TO STABILIZE AT 7ATM AND, A VACUUM PULL (DEFLATION) WAS CONDUCTED. THE BALLOON FULLY DEFLATED IN 30SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390393 NANOCROSS .014" OTW PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COVIDIEN AB14W040040150 9772709

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Other