BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERCROSS .035" OTW PTA DILATATION CATHETER

    MDR report key: 3883890 · Received June 19, 2014

    Report

    Report Number
    2183870-2014-00143
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    April 15, 2014
    Report Date
    May 23, 2014
    Manufacturer
    COVIDIEN
    Product Code
    LIT
    PMA / PMN Number
    K110319
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS PROCEDURE OF PTA OF THE AFS WAS PERFORMED IN (B)(6). THE EVERCROSS BALLOON WAS INFLATED TO 12 ATM (RATED BURST IS 11ATM) AT THE LEVEL OF THE STENOSIS. THE BALLOON BURST, AND THE PHYSICIAN BEGAN TO REMOVE IT. THE EVERCROSS BECAME STUCK AT THE SHEATH. THE SHEATH HAD TO BE REMOVED WITH THE BALLOON. NO PATIENT INJURED, NO INTERVENTION NECESSARY, NO EXTENSION OF THE PROCEDURE TIME. REFERENCE MDR 2183870-2014-00142 FOR THE OTHER EVERCROSS USED IN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360588 EVERCROSS .035" OTW PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COVIDIEN AB35W06200080 9804356

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EVERCROSS BALLOON| BOSTON SCIENTIFIC ZIP WIRE