BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    MDR report key: 9454107 · Received December 11, 2019

    Report

    Report Number
    2522007-2019-00026
    Event Type
    Injury
    Date Received
    December 11, 2019
    Date of Event
    November 12, 2019
    Report Date
    August 27, 2020
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. ADDITIONAL INFORMATION: H6- EC METHOD CODE DESC - 1: DEVICE NOT RETURNED (4114) H6- EC RESULTS CODE DESC - 1: CHANGED TO NO FINDINGS AVAILABLE (3221) H6- EC CONCLUSIONS CODE DESC - 1: CHANGED TO KNOWN INHERENT RISK OF DEVICE (22) H10- ADDED SUMMARY OF INVESTIGATION INVESTIGATION-EVALUATION: NO DEVICE WAS RETURNED TO CVI, THEREFORE A PHYSICAL INVESTIGATION OF THE DEVICE COULD NOT BE PERFORMED. THE COMPLAINT/EVENT THAT WAS ENTERED INTO TRACKWISE: "AS STATED IN LITERATURE FINDING, "ONLY ONE MAJOR COMPLICATION (SUBCLAVIAN VEIN TEAR) WHICH REQUIRED SURGICAL REPAIR." PER LITERATURE: "EVENTS ARE CLASSIFIED AS MAJOR OR MINOR ACCORDING TO SEVERITY: MAJOR COMPLICATIONS: THOSE THAT CREATE A LIFE-THREATENING SITUATION OR REQUIRE A MAJOR INTERVENTION FOR THEIR RESOLUTION OR RESULT IN DEATH, E.G. CARDIAC AVULSION AND VASCULAR TEAR REQUIRING SURGICAL REPAIR." THE DEVICE HISTORY RECORD COULD NOT BE VIEWED DUE TO THE LOT IS UNKNOWN. THIS COMPLAINT WILL BE MONITORED AND TRENDED THROUGH THE CVI COMPLAINT HANDLING AND POST MARKED SURVEILLANCE PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED PER QERA 200306.1 AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB OF TRACKWISE. PER IFU (D00078684 REV002): "IF EXCESSIVE SCAR TISSUE OR CALCIFICATION PREVENTS SAFE ADVANCEMENT OF SHEATHES, CONSIDER AN ALTERNATE APPROACH.", EXCESSIVE FORCE WITH SHEATHS, INCLUDING THE EVOLUTION OR EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET USED INTRAVASCULARLY MAY RESULT IN DAMAGE TO THE VASCULAR SYSTEM REQUIRING SURGICAL REPAIR.", AND "CATHETER/LEAD REMOVAL DEVICES SHOULD BE USED ONLY BY PHYSICIANS KNOWLEDGEABLE IN THE TECHNIQUES AND DEVICES FOR CATHETER/LEAD REMOVAL."

    Description of Event or Problem · 0

    AS STATED IN LITERATURE FINDING,"ONLY ONE MAJOR COMPLICATION (SUBCLAVIAN VEIN TEAR) WHICH REQUIRED SURGICAL REPAIR BY A VASCULAR SURGEON."

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DRE. CONCOMITANT PRODUCTS: COOK LIBERATOR® BEACON® TIP LOCKING STYLET (LR-OFA01). PMA/510(K): K142301. (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE ATTACHED LITERATURE FINDING THAT DURING A CASE STUDY FOCUSED ON COMPLICATIONS FOR LEAD EXTRACTION PROCEDURES,"ONLY ONE MAJOR COMPLICATION (SUBCLAVIAN VEIN TEAR) WHICH REQUIRED SURGICAL REPAIR BY A VASCULAR SURGEON" OCCURRED. THE MAJOR COMPLICATION SITED IN THE LITERATURE FINDING IS SITES AS A SUBCLAVIAN VEIN TEAR INVOLVING A COOK LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET (LR-EVN-11.0) WHICH REQUIRED NON-SPECIFIED SURGICAL REPAIR BY A VASCULAR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249722 LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VANDERGRIFT INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention