BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    MDR report key: 24792356 · Received April 6, 2026

    Report

    Report Number
    2522007-2026-00008
    Event Type
    Injury
    Date Received
    April 6, 2026
    Date of Event
    August 1, 2017
    Report Date
    April 6, 2026
    Manufacturer
    COOK VANDERGRIFT INC.
    Product Code
    DRB
    UDI-DI
    00827002265509
    PMA / PMN Number
    K170298
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS DISCOVERED IN A CASE REPORT BY MERIT MEDICAL SYSTEMS INC, SPECIFIC TO A LOCKING STYLET. MERIT MEDICAL THEN FORWARDED THE INFORMATION TO COOK MEDICAL. THE CASE REPORT CONTAINED LIMITED INFORMATION. A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AS THE DEVICE WAS NOT RETURNED. THE CUSTOMER'S EVENT IS ACKNOWLEDGED, BUT COULD NOT BE CONFIRMED, OTHER THAN BY THE INFORMATION DETAILED WITHIN THE CASE STUDY. THE CASE REPORT INDICATED THE DATE OF THE EVENT AS AUG. 2017; THEREFORE, THE DATE OF EVENT WAS SELECTED AS AUG. 1, 2017, SINCE THE EXACT DATE WAS UNKNOWN. THE LOCATION FOR THE EVENT WAS DETERMINED BY THE MAJORITY OF AUTHORS OF THE ARTICLE WERE FROM THE ELECTROPHYSIOLOGY UNIT, CLINICA MONTEVERGINE, IN MERCOGLIANO, ITALY. THE APPLICABLE MODEL NUMBER FOR THIS EVENT IS CONFIRMED AS THERE IS ONLY ONE MODEL OF THE LIBERATOR BEACON TIP LOCKING STYLET. THERE WERE NO DETAILS PROVIDED IN THE CASE REPORT TO INDICATE THAT A COOK MEDICAL DEVICE MALFUNCTIONED. THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE VIEWED DUE TO THE LOT NUMBER SPECIFIC TO THIS COMPLAINT WAS UNKNOWN. THIS EVENT IS BEING MONITORED, TRACKED AND TRENDED PER THE COOK VANDERGRIFT, INC. (CVI) POST MARKET SURVEILLANCE AND COMPLAINT HANDLING PROCESSES. PER THE DEVICE'S INSTRUCTIONS FOR USE: "WHEN USING THE LIBERATOR BEACON TIP LOCKING STYLET: DO NOT ABANDON A CATHETER/LEAD IN A PATIENT WITH THE LIBERATOR BEACON TIP LOCKING STYLET STILL IN PLACE INSIDE THE CATHETER/LEAD. SEVERE VESSEL OR ENDOCARDIAL WALL DAMAGE MAY RESULT FROM THE STIFFENED CATHETER/LEAD OR FROM FRACTURE OR MIGRATION OF THE ABANDONED STYLET WIRE. DO NOT APPLY WEIGHTED TRACTION TO AN INSERTED LIBERATOR BEACON TIP LOCKING STYLET AS MYOCARDIAL AVULSION, HYPOTENSION, OR VENOUS WALL TEARING MAY RESULT. BE AWARE THAT A LEAD THAT HAS A J-SHAPE RETENTION WIRE THAT OCCUPIES ITS INNER LUMEN (RATHER THAN BEING OUTSIDE THE COIL) MAY NOT BE COMPATIBLE WITH THE LIBERATOR BEACON TIP LOCKING STYLET. INSERTION OF THE LIBERATOR BEACON TIP LOCKING STYLET INTO SUCH A LEAD MAY RESULT IN PROTRUSION AND POSSIBLE MIGRATION OF THE J-SHAPE RETENTION WIRE.", "HAVE AVAILABLE AN EXTENSIVE COLLECTION OF SHEATHS, LOCKING STYLETS, STYLETS TO UNSCREW ACTIVE FIXATION LEADS, SNARES, AND ACCESSORY EQUIPMENT.", "NOTE: EXAMINE THE LUMEN TO BE SURE THE INTERIOR COIL IS NOT FLATTENED AND THERE ARE NO BURRS THAT WOULD INHIBIT PASSAGE OF THE LIBERATOR BEACON TIP LOCKING STYLET INTO THE LUMEN.", "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, CARDIAC TAMPONADE, HEMOPERICARDIUM/PERICARDIAL EFFUSION, 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.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION IS EXCERPTED FROM A CASE REPORT TITLED, "HIGHLY COMPLICATED LEAD EXTRACTION PROCEDURE IN PATIENT WITH PREVIOUS EARLY ORTHOTOPIC HEART TRANSPLANTATION: A FIRST CASE REPORT" (SCHILLACI, ET AL.). AN RV [RIGHT VENTRICULAR] LEAD ACTIVE FIXATION WAS UNSCREWED FROM THE ENDOCARDIUM, AND A LOCKING STYLET (LIBERATOR COOK MEDICAL, BLOOMINGTON, IN, USA) WAS EXCHANGED WITH THE STANDARD ONE. THE [LIBERATOR] LOCKING STYLET WAS HARDLY ADVANCED TILL OBSTRUCTION SITE, AND SIMPLE TRACTION WAS ATTEMPTED. THE SIMPLE TRACTION PROVED UNSUCCESSFUL, AND A NEW ATTEMPT WAS PERFORMED USING A LASER DILATOR SHEATH (SPECTRANETICS 14FR, COLORADO SPRINGS, CO) ADVANCED OVER THE [LIBERATOR] LEAD/LOCKING STYLET COMPLEX. HOWEVER, IT WAS NOT POSSIBLE TO ADVANCE THE LASER DILATOR SHEATH OVER THE OBSTRUCTION DUE TO THE PRESENCE OF IMPORTANT CALCIFICATION AT SUPERIOR VENA CAVA/JUNCTION OF THE BRACHIOCEPHALIC VEINS. MOREOVER, DURING THE LEAD TRACTION, A DISTAL COIL MIGRATION TO THE CAVOATRIAL JUNCTION (CAJ) OCCURRED, AND RV LEAD FRACTURED PROXIMALLY TO THE OBSTRUCTION. ABOUT LV [LEFT VENTRICULAR] LEAD REMOVAL, THE LOCKING STYLET (LIBERATOR COOK MEDICAL) WAS NOT ADVANCED TO THE DISTAL PORTION DUE TO MULTIPLE LEAD¿S FRACTURES, AND A BULLDOG LEAD EXTENDER SYSTEM (COOK MEDICAL) WAS USED FOR THE FIXATION OF LEAD. A LASER DILATOR SHEATH (SPECTRANETRICS, 14FR) WAS USED TO PERFORM THE LV LEAD EXTRACTION, BUT AGAIN A DISTAL LEAD MIGRATION TO THE CAJ OCCURRED AND LV LEAD FRACTURED PROXIMALLY. FINALLY, THE PATIENT HAD A GOOD RA [RIGHT ATRIAL] LEAD PERFORMANCE, AND ACCORDINGLY A GOOD SITE IN THE RIGHT ATRIAL APPENDAGE (RAA) WAS FOUND. AT THIS POINT, THEY DECIDED TO STOP THE PROCEDURE IN ORDER TO ACHIEVE THE OPTIMAL STRATEGY. AT THE END OF PROCEDURE, THE ECHOCARDIOGRAM REVEALED NO PERICARDIAL EFFUSION. CHEST X-RAY CONFIRMED THE PRESENCE OF TWO FRAGMENTS. TWO DAYS LATER, WHETHER ALSO THE WBC [WHITE BLOOD CELL] AND THE HEMOGLOBIN WERE WITHIN THE REFERENCE RANGE, A FEMORAL APPROACH LEAD EXTRACTION WAS PERFORMED ADVANCING A 16 FRENCH LONG SHEATH THROUGH THE RIGHT ILIAC VEIN (NEEDLE¿S EYE SNARE, COOK MEDICAL) WITH COMPLETE PROCEDURAL SUCCESS. AT THE TIME OF THE PATIENT'S DISCHARGE FROM THE HOSPITAL, THE PATIENT REMAINED ASYMPTOMATIC WITH NORMAL ECHOCARDIOGRAM, CHEST X-RAY, AND BLOOD EXAMINATION VALUES. THERE WAS NO ALLEGATION OR INDICATION THAT THERE WAS A MALFUNCTION OF A COOK DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850183 LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET DRB STYLET, CATHETER DRB COOK VANDERGRIFT INC. G26550 00827002265509

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Life Threatening| R COOK BULLDOG LEAD EXTENDER SYSTEM| LASER DILATOR SHEATH (SPECTRANETICS, 14F)