BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    MDR report key: 6489986 · Received April 13, 2017

    Report

    Report Number
    2522007-2017-00013
    Event Type
    Injury
    Date Received
    April 13, 2017
    Date of Event
    March 14, 2017
    Report Date
    July 12, 2017
    Manufacturer
    COOK VASCULAR INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF DOCUMENTATION, AND COMPLAINT HISTORY WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE PHYSICAL EXAMINATION OF THE DEVICE BY THE QUALITY ENGINEERING AND/OR ENGINEERING DEPARTMENTS COULD NOT BE PERFORMED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE COMPLAINT LOT NUMBER WAS NOT PROVIDED. BASED ON THE PROVIDED INFORMATION A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED OR REPORTED AT THIS TIME. WE WILL NOTIFY THE APPROPRIATE PERSONNEL AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA# - K142301. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A PERFORATION AT THE UPPER SUPERIOR VENA CAVA (SVC). THE PHYSICIAN ORIGINALLY STARTED THE PROCEDURE BY USING TWO DIFFERENT DEVICES FROM ANOTHER MANUFACTURER. IT WAS REPORTED THAT BOTH DEVICES FAILED TO REMOVE THE LEAD. THE PHYSICIAN SWITCHED TO THE LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET. THERE WAS A FIVE MINUTES GAP REPORTED BETWEEN THE USE OF THE OTHER DEVICES AND THE LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO EXTRACT THE LEAD WITH THE LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET. HOWEVER, ONE MINUTE POST EXTRACTION, THE PATIENT¿S BLOOD PRESSURE DROPPED AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) SHOWED MASSIVE BLEEDING. IT WAS REPORTED THAT AN IMMEDIATE INSERTION OF THE DEVICE FROM ANOTHER MANUFACTURER STOPPED THE BLEEDING AND THE PATIENT¿S CHEST WAS OPENED FOR A SURGICAL SOLUTION. SEVERAL INQUIRIES WERE MADE ABOUT THE LOT NUMBER AND EXPIRATION DATE OF THE DEVICE, HOWEVER AT THIS TIME NO FURTHER INFORMATION IS AVAILABLE ABOUT THE PRODUCT THAT WAS USED. THEREFORE, IT IS UNKNOWN IF THE PHYSICIAN ACTUALLY USED EXPIRED PRODUCT. PATIENT OUTCOME IS UNKNOWN AS INFORMATION NOT PROVIDED BY REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273597 LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention