BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER

    MDR report key: 9213339 · Received October 21, 2019

    Report

    Report Number
    2183870-2019-00512
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Date of Event
    October 18, 2019
    Report Date
    January 28, 2020
    Manufacturer
    COVIDIEN
    Product Code
    LIT
    UDI-DI
    00763000110369
    PMA / PMN Number
    K132777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE BALLOON WAS INFLATED TO NOMINAL PRESSURE DURING PRE AND POST DILATION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PHYSICIAN INTENDED TO USE A NANOCROSS ELITE WITH A 6FR NON-MEDTRONIC SHEATH AND 7MM SPIDER FX DEVICE DURING TREATMENT OF A 150MM FIBROUS LESION IN THE PATIENT¿S MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6MM. THE VESSEL IS DESCRIBED AS BEING NON-TORTUOUS AND SLIGHTLY CALCIFIED. LESION EXHIBITED 80% STENOSIS. PRE-DILATION WAS PERFORMED USING THE NANOCROSS ELITE. THE BALLOON WAS INFLATED WITH A CONTRAST/SALINE MIX USING A NON-MEDTRONIC INFLATION DEVICE. THE BALLOON WAS REMOVED AND A NON-MEDTRONIC STENT WAS PLACED. THE NANOCROSS BALLOON WAS REINSERTED TO POST-DILATE. THE BALLOON INFLATED AS NORMAL BUT WOULD NOT DEFLATE. AFTER MULTIPLE REINFLATIONS AND DEFLATIONS, AND UTILIZING A LARGE SYRINGE ON THE STOP COCK, THE BALLOON WAS DEFLATED SUCCESSFULLY AND REMOVED. TOTAL DEFLATION TIME REPORTED AS 240 SECONDS. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009681 NANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COVIDIEN AB14W050200150 A862913 00763000110369

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR