BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGHTRAIL ROTATING DILATOR SHEATH

    MDR report key: 19274521 · Received May 8, 2024

    Report

    Report Number
    3007284006-2024-00085
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    April 11, 2024
    Report Date
    May 8, 2024
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    DRE
    UDI-DI
    00813132021658
    PMA / PMN Number
    K150360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED, THUS NO INVESTIGATION COULD BE COMPLETED. PERFORATION OF VESSELS AND GREAT VESSEL PERFORATION ARE KNOWN RISKS OF COMPLICATION WITH USE OF THE TIGHTRAIL DEVICE. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Description of Event or Problem · 0

    A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO NON FUNCTION AND OCCLUSION. A RIGHT ATRIAL (RA) AND A LEFT VENTRICULAR (LV) LEAD WERE PRESENT IN THE PATIENT AS WELL, BUT WERE NOT INITIALLY TARGETED FOR EXTRACTION. A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD EZ) WAS INSERTED INTO THE RV LEAD TO PROVIDE TRACTION. BEGINNING WITH AN XCARDIA INNOVATION LTD XTRACTOR DEVICE, THERE WAS ADVANCEMENT ONLY TO THE CLAVICLE. NEXT, A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH WAS USED TO ADVANCE TO THE INNOMINATE/SUPERIOR VENA CAVA (SVC) JUNCTION, AND PROGRESS STALLED. THEN, A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH AND A SPECTRANETICS VISISHEATH DILATOR SHEATH WERE USED TO ADVANCE SLIGHTLY, WHEN IT WAS NOTED THAT THE RA AND LV LEADS WERE BUNCHING IN FRONT OF THE GLIDELIGHT, PREVENTING FURTHER PROGRESS. SWITCHING BACK TO THE TIGHTRAIL, SEVERAL MORE ATTEMPTS WERE MADE ON THE RV LEAD WITHOUT SUCCESS, AND IT WAS DECIDED TO EXTRACT THE RA LEAD TO HOPEFULLY ALLOW RV LEAD REMOVAL. AN LLD EZ WAS INSERTED INTO THE RA LEAD TO PROVIDE TRACTION, AND THE LEAD WAS SNARED FROM A FEMORAL APPROACH, AND THE TIGHTRAIL WAS USED TO FREE THE LEAD. DESIRING TO MAINTAIN ACCESS FOR RE-IMPLANTATION, A COOK MEDICAL ONE-TIE COMPRESSION COIL WAS USED TO ATTACH AN ABBOTT WHISPER GUIDE WIRE TO THE PROXIMAL END OF THE LLD EZ. USING THE SNARE, PLANS WERE MADE TO PULL THE RA LEAD, LLD EZ, ONE-TIE AND WHISPER GUIDE WIRE THROUGH THE VASCULATURE INTO THE INFERIOR VENA CAVA (IVC) AND OUT THROUGH THE GROIN, INSTEAD OF REMOVING THE DEVICES FROM THE POCKET. DUE TO POTENTIAL FOR INJURY, CAUTION WAS COMMUNICATED REGARDING PULLING THE DEVICES THROUGH THE BODY IN THIS MANNER; HOWEVER, THE PROCEDURE CONTINUED. DUE TO RESISTANCE, THE TIGHTRAIL WAS PULLED BACK ALMOST ALL THE WAY OUT OF THE POCKET, AND THE OTHER DEVICES WERE PULLED THROUGH THE VASCULATURE AND OUT THE GROIN. AT THAT TIME, THE PATIENT'S BLOOD PRESSURE DROPPED AND AN EFFUSION WAS NOTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). RESCUE EFFORTS BEGAN IMMEDIATELY INCLUDING RESCUE BALLOON AND STERNOTOMY. A VERY LARGE PERFORATION IN THE INNOMINATE REGION WAS DISCOVERED WHICH WAS DIFFICULT TO ACCESS, AND ANOTHER SMALL PERFORATION WAS NOTED IN THE SVC. REPAIRS WERE COMPLETED, THE RV LEAD WAS REMOVED POST-STERNOTOMY, AND THE PATIENT SURVIVED THE PROCEDURE. THE PHYSICIAN BELIEVED THE PERFORATIONS OCCURRED DUE TO THE CUMULATIVE EFFECT OF NUMEROUS DEVICES PASSING THROUGH THE INNOMINATE AREA DURING THE EXTRACTION, AND NOT FROM PULLING THE DEVICES THROUGH THE VASCULATURE. THIS REPORT CAPTURES THE 13F TIGHTRAIL, THE LAST DEVICE USED IN THE AREA OF THE PERFORATIONS, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520415 TIGHTRAIL ROTATING DILATOR SHEATH DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE SPECTRANETICS CORPORATION 545-513 FRJ23M14A 00813132021658

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Life Threatening| R ABBOTT WHISPER GUIDE WIRE| COOK MEDICAL ONE-TIE COMPRESSION COIL| MEDTRONIC 4196 LV LEAD| MEDTRONIC 5076 RA PACING LEAD| MEDTRONIC 6935M RV PACING LEAD| SNARE MANUFACTURER/TYPE UNK| SPECTRANETICS 16F GLIDELIGHT LASER SHEATH| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| SPECTRANETICS LLD EZS IN RV AND RA LEADS| SPECTRANETICS VISISHEATH DILATOR SHEATH| XCARDIA INNOVATION LTD XTRACTOR DEVICE