BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 22725602 · Received August 6, 2025

    Report

    Report Number
    2522007-2025-00014
    Event Type
    Injury
    Date Received
    August 6, 2025
    Date of Event
    July 11, 2025
    Report Date
    February 9, 2026
    Manufacturer
    COOK VANDERGRIFT INC.
    Product Code
    DRE
    UDI-DI
    10827002237466
    PMA / PMN Number
    K141148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE MANUFACTURER'S INVESTIGATION, TO PROVIDE ADDITIONAL INFORMATION, TO INCLUDE INFORMATION THAT WAS INADVERTENTLY NOT INCLUDED IN THE INITIAL REPORT (B7 AND G3), AND TO CORRECT INFORMATION THAT WAS PREVIOUSLY SUBMITTED (CORRECTION TO 7A: NO). G3 IN THE INITIAL REPORT SHOULD HAVE BEEN IDENTIFIED AS JULY 11, 2025. THE DEVICE WAS NOT RETURNED FOR THE COMPLAINT; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED DUE TO THE LOT WAS UNKNOWN SPECIFIC TO THE DEVICE WITHIN THIS COMPLAINT. THE CUSTOMER'S COMPLAINT IS ACKNOWLEDGED, BUT COULD NOT BE CONFIRMED, OTHER THAN BY THE CUSTOMER'S TESTIMONY. THIS COMPLAINT MODE WILL BE TRACKED, TRENDED AND MONITORED IN CVI COMPLAINT HANDLING AND POST MARKET SURVEILLANCE PROCEDURES. ACCORDING TO THE COMPLAINT DETAILS, THERE WAS NO ALLEGATION OR EVIDENCE OF A DEVICE MALFUNCTION OF THE SUBJECT DEVICE. THE FOLLOWING INFORMATION IS CONTAINED IN THE DEVICE'S INSTRUCTIONS FOR USE: "WHEN USING SHEATHS, DO NOT INSERT SHEATHS OVER MORE THAN ONE LEAD AT A TIME. SEVERE VESSEL DAMAGE, INCLUDING VENOUS WALL LACERATION REQUIRING SURGICAL REPAIR, MAY OCCUR.", "ESTABLISH BACK UP PACING AS NECESSARY.", "HAVE AVAILABLE AN EXTENSIVE COLLECTION OF SHEATHS, LEAD CONTROL DEVICES (LOCKING STYLET AND LEAD EXTENDER), STYLETS TO UNSCREW ACTIVE FIXATION LEADS, SNARES, AND ACCESSORY EQUIPMENT.", "WHEN ADVANCING SHEATHS INCLUDING THE EVOLUTION OR EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, USE PROPER SHEATH TECHNIQUE AND MAINTAIN ADEQUATE TENSION ON THE CATHETER/LEAD (VIA A LOCKING STYLET OR DIRECTLY) TO AVOID DAMAGE TO VESSEL WALLS.", "IF EXCESSIVE SCAR TISSUE OR CALCIFICATION PREVENTS SAFE ADVANCEMENT OF SHEATHS, 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.", "IF THE CATHETER/LEAD BREAKS, EVALUATE FRAGMENT; RETRIEVE AS INDICATED.", "IF HYPOTENSION DEVELOPS, RAPIDLY EVALUATE; TREAT AS APPROPRIATE."", "POTENTIAL ADVERSE EVENTS RELATED TO THE PROCEDURE OF INTRAVASCULAR EXTRACTION OF CATHETERS/LEADS INCLUDE (LISTED IN ORDER OF INCREASING POTENTIAL EFFECT): DISLODGING OR DAMAGING NONTARGETED CATHETER/LEAD, CHEST WALL HEMATOMA, THROMBOSIS, ARRHYTHMIAS, ACUTE BACTEREMIA, ACUTE HYPOTENSION, PNEUMOTHORAX, STROKE, MIGRATING FRAGMENT FROM CATHETER/OBJECT, PULMONARY EMBOLISM, LACERATION OR TEARING OF VASCULAR STRUCTURES OR THE MYOCARDIUM, HEMOPERICARDIUM/PERICARDIAL EFFUSION, CARDIAC TAMPONADE, HEMOTHORAX, CARDIAC ARREST, DEATH." 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.

    Additional Manufacturer Narrative · 0

    THE UDI INFORMATION PER 21CFR 803.52(C)(4) AND 21 CFR 803.50(B) THAT IS REQUIRED IS REASONABLY UNKNOWN DUE TO THE DEVICE ITSELF WAS DISCARDED/NOT RETURNED FOR INVESTIGATION AND THE LOT OF THE DEVICE WAS UNKNOWN. D4 - LOT #: UNKNOWN. D4 - UDI NUMBER: UNKNOWN. E1 - TITLE: UNKNOWN. E1 - ZIP CODE: UNKNOWN. E1 - PHONE NUMBER: UNKNOWN. E1 - FAX NUMBER: UNKNOWN. E1 - EMAIL: UNKNOWN. E1 - OCCUPATION: UNKNOWN. 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. 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

    THE PROCEDURE WAS STARTED AFTER GRASPING THE LEAD FROM THE FEMORAL ARTERY PER RIGHT ATRIUM (RA) WITH A NEEDLE EYE'S SNARE (NES). THE REASON FOR TRACTION FROM BELOW WAS TO MAKE THE SHEATH AND LEAD COAXIAL AND EASY TO DETACH APPROACHING FROM THE UPPER EXTREMITY, AND TO REDUCE THE RISK OF SUPERIOR VENA CAVA (SVC) INJURY. FROM THE UPPER EXTREMITY, WE USED EVOLUTION SHORTIE, EVOLUTION11, AND EVOLUTION13 TO DISSECT THE CORONARY SINUS (CS), BUT THE ADHESION IN THE CS WAS SO STRONG THAT PHYSICIAN DECIDED TO SHIFT TO BYRD DILATOR SHEATH, JUDGING THAT HE COULD NOT REMOVE THE CS WITHOUT SOME DISSECTION INSIDE IT. HOWEVER, IT COULD NOT FOLLOW THE FLEXION AND KINKED. HE SWITCHED TO EVOLUTION 11 AGAIN, MAINTAINED THE SHEATH TIP NEAR THE CS, AND SLOWLY ROTATED AND APPLIED TRACTION, WHICH ALLOWED US TO REMOVE IT. IMMEDIATELY AFTERWARDS, THE BLOOD PRESSURE GRADUALLY DROPPED, PERICARDIAL FLUID ACCUMULATION WAS CONFIRMED, AND PERICARDIOCENTESIS WAS ATTEMPTED. AFTER OBSERVING THE PATIENT FOR ABOUT AN HOUR, IT WAS DETERMINED THAT THE PATIENT HAD STABILIZED AND A DECISION WAS MADE NOT TO PERFORM A THORACOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528099 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION DRE COOK VANDERGRIFT INC. G23746 10827002237466

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BYRD DILATOR SHEATH| EVOLUTION® RL CONTROLLED-ROTATION DILATOR SHEATH S| EVOLUTION® SHORTIE RL CONTROLLED-ROTATION DILATOR| NEEDLE¿S EYE SNARE