BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    MDR report key: 20532038 · Received October 25, 2024

    Report

    Report Number
    2522007-2024-00039
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    October 22, 2024
    Report Date
    November 21, 2024
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 AFTER MANUFACTURER REQUESTED FOR THE RETURN AND THE LOT OF THE DEVICE WAS 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. G5 ¿ PMA/510(K): K170298. E3 - OCCUPATION: (B)(6). 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 AFTER MANUFACTURER REQUESTED FOR THE RETURN AND THE LOT OF THE DEVICE WAS UNKNOWN. 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. THE CUSTOMER COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "COMPLICATIONS OF SVC DAMAGE OCCURRED DURING A CASE OF COOK PRODUCT USE." PER COMPLAINT INFORMATION, IT WAS STATED THAT "THE USE OF THE PHILPS' GLIDELIGHT (LASER SHEATH) HAD DAMAGED THE SVC AND CAUSED A DROP IN BLOOD PRESSURE...." THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE VIEWED DUE TO THE LOT NUMBER SPECIFIC TO THIS COMPLAINT WAS UNKNOWN. THIS COMPLAINT MODE IS BEING MONITORED, TRACKED AND TRENDED PER THE CVI POST MARKET SURVEILLANCE AND COMPLAINT HANDLING PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB IN TRACKWISE. G5 ¿ PMA/510(K): K170298. 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

    COOK PRODUCTS INVOLVED: LR-OFA01 (LOT UNKNOWN) LR-EVN (LOT UNKNOWN). DURING REMOVAL OF A DUAL-CHAMBER PACEMAKER LEAD, THE LEAD WAS BEING DETACHED FROM THE ADHERENT TISSUE USING A PHILIPS GLIDELIGHT (LASER SHEATH), AND BLOOD PRESSURE DECREASED. THE PATIENT WAS CONNECTED TO A CARDIOPULMONARY BYPASS MACHINE, AND ONCE BLOOD PRESSURE HAD STABILIZED, THE LEAD WAS REMOVED USING EVOLUTION. THE SVC (SUPERIOR VENA CAVA) APPEARED TO HAVE BEEN DAMAGED, SO A MEDIAN STERNOTOMY WAS PERFORMED AND THE DAMAGED AREA WAS REPAIRED.

    Description of Event or Problem · 0

    COOK PRODUCTS INVOLVED: LR-OFA01 (LOT UNKNOWN). LR-EVN (LOT UNKNOWN). DURING REMOVAL OF A DUAL-CHAMBER (DDD) PACEMAKER LEAD, THE LEAD WAS BEING DETACHED FROM THE ADHERENT TISSUE USING A PHILIPS GLIDELIGHT (LASER SHEATH), AND BLOOD PRESSURE DECREASED. THE PATIENT WAS CONNECTED TO A CARDIOPULMONARY BYPASS MACHINE, AND ONCE BLOOD PRESSURE HAD STABILIZED, THE LEAD WAS REMOVED USING EVOLUTION. THE SVC (SUPERIOR VENA CAVA) APPEARED TO HAVE BEEN DAMAGED, SO A MEDIAN STERNOTOMY WAS PERFORMED, AND THE DAMAGED AREA WAS REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812056 LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET DQX WIRE, GUIDE, CATHETER DQX COOK VANDERGRIFT INC G26550 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other LR-EVN DEVICE.| PHILIPS GLIDELIGHT.