BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 14632579 · Received June 8, 2022

    Report

    Report Number
    2522007-2022-00016
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    May 20, 2022
    Report Date
    July 11, 2022
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE: DRE. PMA/510 (K): K141148. THE EVENT IS CURRENTLY UNDER INVESTIGATION. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE OR UPON COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    D2B: PRODUCT CODE: DRE. G5: PMA/510 (K): K141148. INVESTIGATION - EVALUATION: A DEVICE WAS NOT RETURNED ON THIS COMPLAINT, THEREFORE A PHYSICAL INVESTIGATION COULD BE PERFORMED AND THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED OTHER THAN BY TESTIMONY. THE CUSTOMER COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "UPON THE LEAD RELEASING FROM THE RIGHT ATRIUM, THE EVOLUTION RL WENT THROUGH THE SVC." ACCORDING TO THE INFORMATION PROVIDED IN TRACKWISE, THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IT WAS STATED "LEFT SIDED LEAD EXTRACTION WITH TWO LEADS IN THE RIGHT ATRIUM. UPON THE LEAD RELEASING FROM THE RIGHT ATRIUM, THE EVOLUTION RL WENT THROUGH THE SVC. THE PHYSICIAN THEN PERFORMED A STERNOTOMY AND REPAIRED THE TEAR." IT WAS STATED THAT THE "STERNOTOMY PERFORMED TO REPAIR SVC TEAR. PATIENT PLACED ON PUMP." ALONG WITH THE "SVC TEAR REQUIRING SURGICAL INTERVENTION AND REPAIR." THE DEVICE OR EVENT THAT CAUSED THE BLEEDING HOWEVER IS UNKNOWN. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, INCLUDING MANUFACTURING AND QUALITY CONTROL RECORDS AND THERE ARE NO SIGNS TO INDICATE THAT THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. THIS COMPLAINT MODE IS BEING MONITORED, TRACKED AND TRENDED PER THE CVI POST MARKET SURVEILLANCE AND COMPLAINT HANDLING PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB IN TRACKWISE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    LEFT SIDED LEAD EXTRACTION WITH TWO LEADS IN THE RIGHT ATRIUM. UPON THE LEAD RELEASING FROM THE RIGHT ATRIUM, THE EVOLUTION RL WENT THROUGH THE SVC. THE PHYSICIAN THEN PERFORMED A STERNOTOMY AND REPAIRED THE TEAR.

    Description of Event or Problem · 0

    LEFT SIDED LEAD EXTRACTION WITH TWO LEADS IN THE RIGHT ATRIUM. UPON THE LEAD RELEASING FROM THE RIGHT ATRIUM, THE EVOLUTION RL WENT THROUGH THE SVC. THE PHYSICIAN THEN PERFORMED A STERNOTOMY AND REPAIRED THE TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12390 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VANDERGRIFT INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention EVOLUTION RL| EVOLUTION RL| EVOLUTION SHORTIE RL| EVOLUTION SHORTIE RL| LIBERATOR| LIBERATOR| ONE-TIE| ONE-TIE| STEADYSHEATH| STEADYSHEATH