BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONE-TIE COMPRESSION COIL

    MDR report key: 24887545 · Received April 15, 2026

    Report

    Report Number
    2522007-2026-00009
    Event Type
    Death
    Date Received
    April 15, 2026
    Date of Event
    November 4, 2023
    Report Date
    April 15, 2026
    Manufacturer
    COOK VANDERGRIFT, INC.
    Product Code
    DWS
    UDI-DI
    00827002319295
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 - PHONE NUMBER: (B)(6). THE REFERENCED STUDY CONTAINED LIMITED INFORMATION. A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AS THE DEVICE WAS NOT RETURNED. THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE VIEWED DUE TO THE LOT NUMBER SPECIFIC TO THIS EVENT WAS UNKNOWN. THE CUSTOMER'S EVENT IS ACKNOWLEDGED, BUT COULD NOT BE CONFIRMED, OTHER THAN BY THE INFORMATION DETAILED WITHIN THE JOURNAL ARTICLE. (REFER TO ATTACHMENTS OF THIS EMDR FOR A COPY OF THE JOURNAL ARTICLE.) THE JOURNAL ARTICLE INDICATED THE DATE RANGE OF THE EVENT AS DECEMBER 2020 AND MARCH 2023; THEREFORE, THE DATE OF EVENT WAS SELECTED AS NOV. 4, 2023 (PUBLISHED DATE), SINCE THE EXACT DATE OF THE EVENT WAS UNKNOWN. THE LOCATION FOR THE EVENT WAS DETERMINED BY THE MAJORITY OF AUTHORS OF THE ARTICLE WERE FROM THE DEPARTMENT OF CARDIOLOGY AT ST. GEORGE'S HOSPITAL, IN LONDON, UNITED KINGDOM. THE CORRESPONDING AUTHOR OF THE JOURNAL ARTICLE WAS CONTACTED VIA EMAIL IN AN ATTEMPT TO OBTAIN THE SPECIFIC MODEL NUMBERS, DEVICES, LOT NUMBERS, AND DATES OF EVENTS FOR THE COOK MEDICAL DEVICES THAT WERE UTILIZED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED AS OF THE DATE OF THIS REPORT. THE APPLICABLE MODEL NUMBER FOR THIS EVENT WAS ABLE TO BE DETERMINED, AS THERE IS ONLY ONE MODEL OF THE ONE-TIE COMPRESSION COIL. THERE WERE NO DETAILS PROVIDED IN THE JOURNAL ARTICLE TO INDICATE THAT A COOK MEDICAL DEVICE MALFUNCTIONED. THE TANDEM APPROACH TO TRANSVENOUS LEAD EXTRACTION REPRESENTS AN OFF-LABEL PROCEDURAL USE OF FDA-CLEARED COOK MEDICAL LEAD EXTRACTION DEVICES, AS THE SIMULTANEOUS SUPERIOR AND FEMORAL EXTRACTION TECHNIQUE IS NOT SPECIFICALLY DESCRIBED IN DEVICE LABELING. CLINICAL USE IS BASED ON PHYSICIAN JUDGMENT AND SUPPORTED BY PEER REVIEWED LITERATURE. PER THE DEVICE'S INSTRUCTIONS FOR USE (IFU): "WARNING: USE ONLY WITH COOK LOCKING STYLETS.", "GRASP BOTH HANDLES OF ONE-TIE AND BEGIN TO TWIST HANDLES IN OPPOSITE DIRECTIONS WHILE APPLYING ADEQUATE PULLING FORCE WITH BOTH HANDS TO CINCH DOWN ONE-TIE.", "PULL ON COOK LOCKING STYLET TO ENSURE ONE-TIE IS SECURED." THIS EVENT IS BEING MONITORED, TRACKED AND TRENDED PER THE COOK VANDERGRIFT, INC. (CVI) POST MARKET SURVEILLANCE AND COMPLAINT HANDLING PROCESSES. 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

    A MERIT MEDICAL EMPLOYEE CONDUCTED A POST-MARKET CLINICAL FOLLOW UP (PMCF) REVIEW FOR THE MERIT LEAD SUPPORT DEVICES. MERIT MEDICAL THEN FORWARDED THE STUDY INFORMATION TO COOK MEDICAL. THE REFERENCED JOURNAL ARTICLE/STUDY ("TRANSVENOUS LEAD EXTRACTION: EXPERIENCE OF THE TANDEM APPROACH", AKHTAR, ET AL.) DESCRIBES THE USE OF A TANDEM APPROACH DURING TRANSVENOUS LEAD EXTRACTION PROCEDURES IN PATIENTS WITH CHRONICALLY IMPLANTED CARDIAC DEVICES WITH LEADS. THE ONE-TIE COMPRESSION COIL WAS USED TO STABILIZE THE LEAD AND IMPROVE TRACTION DURING EXTRACTION. COMPLICATIONS REPORTED INCLUDE KNOWN EXTRACTION RISKS SUCH AS VASCULAR INJURY, PERICARDIAL EFFUSION, AND PROCEDURAL COMPLICATIONS RELATED TO LEAD EXTRACTION. NO DEVICE MALFUNCTION OR PERFORMANCE ISSUES ASSOCIATED WITH THE ONE-TIE COMPRESSION COIL WERE REPORTED. HOWEVER, ONE PROCEDURE INVOLVING A 61-YEAR-OLD FEMALE LEAD TO A TEAR IN THE SUPERIOR VENA CAVA TO RIGHT ATRIUM (SVC-RA) JUNCTION RESULTING IN PERICARDIAL TAMPONADE. THIS EVENT REQUIRED STERNOTOMY AND REPAIR OF THE INJURY. THE PATIENT DIED TWO DAYS POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943293 ONE-TIE COMPRESSION COIL DWS, INSTRUMENTS, SURGICAL, CARDIOVASCULAR DWS COOK VANDERGRIFT, INC. 00827002319295

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Death NEEDLE¿S EYE SNARE