BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION STEADYSHEATH EVOLUTION TISSUE STABILIZATION SHEATH

    MDR report key: 22166008 · Received June 9, 2025

    Report

    Report Number
    2522007-2025-00009
    Event Type
    Death
    Date Received
    June 9, 2025
    Date of Event
    May 19, 2025
    Report Date
    December 9, 2025
    Manufacturer
    COOK VANDERGRIFT INC.
    Product Code
    DRE
    UDI-DI
    00827002250833
    PMA / PMN Number
    K142301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATED THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. 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. D4 - PRIMARY UDI NUMBER: UNKNOWN, E1 - FIRST NAME/LAST NAME: UNKNOWN, E1 - POSTAL CODE: (B)(6), E1 - PHONE NUMBER: (B)(6), E3 - 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATED THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. 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. B2 - DATE OF DEATH: UNKNOWN. D4 - PRIMARY UDI NUMBER: UNKNOWN. E1 - FIRST NAME/LAST NAME: UNKNOWN. E1 - POSTAL CODE: (B)(6). E1 - PHONE NUMBER: (B)(6). THE DEVICE WAS NOT RETURNED FOR THE COMPLAINT; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AND THE CUSTOMER'S COMPLAINT IS ACKNOWLEDGED, BUT COULD NOT BE CONFIRMED, OTHER THAN BY THE CUSTOMER'S TESTIMONY. PER FOLLOW UP, IT WAS STATED THAT SINCE THE PATIENT PASSED AWAY WITHOUT RECOVERY AFTER THE DAMAGE TO THE SUPERIOR VENA CAVA OCCURRED, IT IS BELIEVED THAT THE CAUSE WAS DAMAGE TO THE SUPERIOR VENA CAVA. HOWEVER, IT IS UNCLEAR WHETHER THE DAMAGE WAS CAUSED BY THE RELATED DEVICES (GLIDELIGHT14FR, 16FR) OR THE LR-EVN-11.0-RL. THE COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "INJURY TO THE SUPERIOR VENA CAVA.." THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. THERE WERE NO SIGNS THAT THE DEVICE WAS NONCONFORMING OR THAT THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. THIS COMPLAINT MODE WILL BE TRACKED, TRENDED AND MONITORED IN CVI COMPLAINT HANDLING AND POST MARKET SURVEILLANCE PROCEDURES. A RISK ASSESSMENT WILL BE PERFORMED WITHIN 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATED THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. 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. D4 - PRIMARY UDI NUMBER: UNKNOWN. E1 - FIRST NAME/LAST NAME: UNKNOWN. E1 - POSTAL CODE: (B)(6). E1 - PHONE NUMBER: (B)(6). THE EVENT IS CURRENTLY STILL 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

    WE REPORT A CASE IN WHICH SUPERIOR VENA CAVA (SVC) INJURY OCCURRED USING THE FOLLOWING PRODUCTS: EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, STEADYSHEATH EVOLUTION® TISSUE STABILIZATION SHEATH, PHILIPPS/GLIDELIGHT 14FR, PHILIPPS/GLIDELIGHT 16FR, (IT IS UNCLEAR IN WHAT ORDER THE COOK PRODUCT EVOLUTION AND THE PHILIPS PRODUCT GLIDELIGHT WERE USED.). EACH ONE LEAD HAD BEEN PLACED IN THE RIGHT ATRIUM AND RIGHT VENTRICLE. AFTER REMOVAL OF THE ATRIAL LEAD, DURING DISSECTION OF THE AREA AROUND THE SVC FOR REMOVAL OF THE VENTRICULAR LEAD, THE PATIENT BLED AND BECAME HYPOTENSIVE; AN ATTEMPT WAS MADE TO STOP THE BLEEDING WITH A PHILIPPS/BRIDGE OCCULUSION BALLOON, FOLLOWED BY OPEN CHEST SURGERY, WHICH REVEALED AN INJURY OF THE SVC.

    Description of Event or Problem · 0

    WE REPORT A CASE IN WHICH SUPERIOR VENA CAVA (SVC) INJURY OCCURRED USING THE FOLLOWING PRODUCTS: - EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET. - STEADY-SHEATH EVOLUTION® TISSUE STABILIZATION SHEATH. - PHILIPPS/GLIDELIGHT 14FR. - PHILIPPS/GLIDELIGHT 16FR. (IT IS UNCLEAR IN WHAT ORDER THE COOK PRODUCT EVOLUTION AND THE PHILIPS PRODUCT GLIDELIGHT WERE USED.). EACH ONE LEAD HAD BEEN PLACED IN THE RIGHT ATRIUM AND RIGHT VENTRICLE. AFTER REMOVAL OF THE ATRIAL LEAD, DURING DISSECTION OF THE AREA AROUND THE SVC FOR REMOVAL OF THE VENTRICULAR LEAD, THE PATIENT BLED AND BECAME HYPOTENSIVE; AN ATTEMPT WAS MADE TO STOP THE BLEEDING WITH A PHILIPPS/BRIDGE OCCULUSION BALLOON, FOLLOWED BY OPEN CHEST SURGERY, WHICH REVEALED AN INJURY OF THE SVC.

    Description of Event or Problem · 0

    WE REPORT A CASE IN WHICH SUPERIOR VENA CAVA (SVC) INJURY OCCURRED USING THE FOLLOWING PRODUCTS: - EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, - STEADYSHEATH EVOLUTION® TISSUE STABILIZATION SHEATH, - PHILIPPS/GLIDELIGHT 14FR, - PHILIPPS/GLIDELIGHT 16FR (IT IS UNCLEAR IN WHAT ORDER THE COOK PRODUCT EVOLUTION AND THE PHILIPS PRODUCT GLIDELIGHT WERE USED.) EACH ONE LEAD HAD BEEN PLACED IN THE RIGHT ATRIUM AND RIGHT VENTRICLE. AFTER REMOVAL OF THE ATRIAL LEAD, DURING DISSECTION OF THE AREA AROUND THE SVC FOR REMOVAL OF THE VENTRICULAR LEAD, THE PATIENT BLED AND BECAME HYPOTENSIVE; AN ATTEMPT WAS MADE TO STOP THE BLEEDING WITH A PHILIPPS/BRIDGE OCCULUSION BALLOON, FOLLOWED BY OPEN CHEST SURGERY, WHICH REVEALED AN INJURY OF THE SVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401687 LEAD EXTRACTION STEADYSHEATH EVOLUTION TISSUE STABILIZATION SHEATH DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK VANDERGRIFT INC. G25083 N208070 00827002250833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| D BRIDGE OCCULUSION BALLOON.| EVOLUTION® RL CONTROLLED-ROTATION DILATOR SHEATH S.| GLIDELIGHT 14FR.| GLIDELIGHT 16FR.| LR-EVN-11.0-RL.| PHILIPPS/16FR.| PHILIPPS/BRIDGE OCCULUSION BALLOON.| PHILIPPS/GLIDELIGHT14FR.| STEADYSHEATH® EVOLUTION® SHORTIE TISSUE STABILIZAT.