BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 19666915 · Received July 3, 2024

    Report

    Report Number
    2522007-2024-00023
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    July 1, 2024
    Report Date
    September 6, 2024
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    UDI-DI
    10827002237374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATED THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. 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): K141148. 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

    PER THE FOLLOWING D4 - UDI: 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. E3 - OCCUPATION: UNKNOWN TITLE ('DR.' IN SALUTATION). G5 ¿ PMA/510(K): K141148. THE DEVICE WAS DISCARDED AND 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 COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "CARDIAC TAMPONADE". 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 THE COMPLAINT SUMMARY TAB OF 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.

    Description of Event or Problem · 0

    APPROACH VIA THE LEFT SUBCLAVIAN VEIN. BELOW ARE THE DEVICES USED, AND ALL DEVICES WERE NOT DEFECTIVE. -LR-EVN-9.0-RL/N197250. -LR-OFA01/N194396. -500-301/GLIDELIGHT12FR. -LR-EVN-11.0-RL (UNKNOWN LOT). DURING REMOVAL OF THE RA LEAD, 500-301/GLIDELIGHT12FR AND THEN THE LR-EVN-9.0-RL WAS USED TO DETACH THE LEAD TO THE RING ELECTRODE, AFTER CHANGING TO LR-EVN-11.0-RL AND ADVANCING THE SHEATH ALONG THE LEAD, THE RA LEAD CAME LOOSE JUST BEFORE IT REACHED THE RING ELECTRODE. SUBSEQUENTLY, WHILE CHECKING THE PATIENT WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY, HIS BLOOD PRESSURE DROPPED, SO A CARDIOVASCULAR SURGEON PERFORMED A MEDIAN STERNOTOMY AND PERFORMED A REPAIR PROCEDURE ON THE RIGHT ATRIAL APPENDAGE. AFTER THE PROCESS, DR. (B)(6) COMMENTED THAT THE LEAD THAT CAME OUT BROUGHT TISSUE FROM THE RIGHT ATRIAL APPENDAGE WITH IT, WHICH PROBABLY CAUSED CARDIAC TAMPONADE. HE DID NOT THINK IT WAS A COMPLICATION CAUSED BY EVOLUTION.

    Description of Event or Problem · 0

    APPROACH VIA THE LEFT SUBCLAVIAN VEIN. BELOW ARE THE DEVICES USED, AND ALL DEVICES WERE NOT DEFECTIVE. -LR-EVN-9.0-RL/N197250. -LR-OFA01/N194396. -500-301/GLIDELIGHT12FR. -LR-EVN-11.0-RL (UNKNOWN LOT). DURING REMOVAL OF THE RA LEAD, 500-301/GLIDELIGHT12FR AND THEN THE LR-EVN-9.0-RL WAS USED TO DETACH THE LEAD TO THE RING ELECTRODE, AFTER CHANGING TO LR-EVN-11.0-RL AND ADVANCING THE SHEATH ALONG THE LEAD, THE RA LEAD CAME LOOSE JUST BEFORE IT REACHED THE RING ELECTRODE. SUBSEQUENTLY, WHILE CHECKING THE PATIENT WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY, HIS BLOOD PRESSURE DROPPED, SO A CARDIOVASCULAR SURGEON PERFORMED A MEDIAN STERNOTOMY AND PERFORMED A REPAIR PROCEDURE ON THE RIGHT ATRIAL APPENDAGE. AFTER THE PROCESS, DR. SAKAMOTO COMMENTED THAT THE LEAD THAT CAME OUT BROUGHT TISSUE FROM THE RIGHT ATRIAL APPENDAGE WITH IT, WHICH PROBABLY CAUSED CARDIAC TAMPONADE. HE DID NOT THINK IT WAS A COMPLICATION CAUSED BY EVOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821921 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION DRE COOK VANDERGRIFT INC G23737 N197250 10827002237374

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other LR-EVN-11.0-RL.| LR-OFA01.| SPECTRANETICS/500-301/GLIDELIGHT12FR.