BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERCROSS .035" OTW PTA DILATATION CATHETER

    MDR report key: 3894664 · Received June 25, 2014

    Report

    Report Number
    2183870-2014-00150
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    COVIDIEN
    Product Code
    LIT
    PMA / PMN Number
    K110319
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS COMPLAINT 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 (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.

    Description of Event or Problem · 1

    THE PATIENT WAS SCHEDULED FOR AN INTERVENTION ON A FISTULA ON THE RIGHT ARM. A 7F SHORT SHEATH WAS USED. THE EVERCROSS BALLOON WAS INFLATED TWO TIMES AT NOMINAL PRESSURE. BEFORE INFLATING THE THIRD TIME THE TECH PULLED NEGATIVE PRESSURE AND THERE WAS BLOOD RETURNING IN THE ENDOFLATOR. THE EVERCROSS BALLOON WAS PULLED BACK AND BROKE ON THE SHAFT INSIDE THE SHEATH. THE SHEATH WAS THEN TAKEN OUT TO RETRIEVE THE TIP OF THE BALLOON. WHEN INSPECTING THE BALLOON PARTS ON THE BACK TABLE IT WAS REALIZED THAT THE BALLOON ITSELF WAS STILL IN THE PATIENT. THE PHYSICIAN TRIED TO RETRIEVE THE BALLOON WITH TWO DIFFERENT SNARES, HOWEVER, THE BALLOON ENDED UP TRAVELING UP AND INTO THE PULMONARY ARTERY. THE PATIENT WAS TRANSFERRED TO THE ICU AND PUT ON A HEPARIN DRIP FOR FURTHER MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371102 EVERCROSS .035" OTW PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COVIDIEN AB35W12060080 9891008

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| O| R