BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS 16F GLIDELIGHT LASER SHEATH

    MDR report key: 12207593 · Received July 21, 2021

    Report

    Report Number
    1721279-2021-00131
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    May 20, 2021
    Report Date
    June 22, 2021
    Manufacturer
    THE SPECTRANETICS CORPORATION
    Product Code
    MFA
    UDI-DI
    00813132020347
    PMA / PMN Number
    P960042 S069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED, THUS NO INVESTIGATION COULD BE PERFORMED.

    Description of Event or Problem · 1

    ON 22 JUNE 2021, A PHILIPS REPRESENTATIVE BECAME AWARE (WHO WAS NOT PRESENT AT THE PROCEDURE) THAT A LEAD EXTRACTION PROCEDURE COMMENCED ON (B)(6) 2021 TO REMOVE A RIGHT VENTRICULAR (RV) DUAL COIL LEAD DUE TO NOISE (NON FUNCTION). A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RV LEAD TO PROVIDE TRACTION TO AID IN THE LEAD''S EXTRACTION; IT WAS REPORTED THAT THE LLD DID NOT REACH THE LEAD''S DISTAL TIP, BUT WAS USED IN THE PROCEDURE. A RIGHT ATRIAL (RA) LEAD WAS PRESENT IN THE PATIENT AS WELL, BUT WAS NOT TARGETED FOR EXTRACTION. THE PHYSICIAN CHOSE A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH TO EXTRACT THE LEAD. DURING THE ATTEMPTED EXTRACTION, A 1-2CM EFFUSION WAS SEEN. RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS, THE NEEDLE ENTERING THE SUBXISPHISTERNAL REGION, AND 2-3 PASSES WITH THE NEEDLE WERE PERFORMED, DIRECTED TOWARDS THE PATIENT''S LEFT SHOULDER. HOWEVER, NO BLOOD WAS DRAWN BACK, SO PERICARDIOCENTESIS WAS ABANDONED. IT WAS REPORTED THAT A SPECTRANETICS BRIDGE OCCLUDING BALLOON CATHETER WAS THEN INSERTED AND INFLATED (OVER 5 MINUTES LATER) TO PROVIDE HEMOSTASIS IN THE SUPERIOR VENA CAVA (SVC) REGION. IT WAS REPORTED THAT THE BRIDGE BALLOON WAS INITIALLY EFFECTIVE IN PROVIDING HEMOSTASIS; THE TIME FROM BRIDGE DEPLOYMENT TO STERNOTOMY WAS REPORTED AS 20 MINUTES. HOWEVER, WHEN THE SURGEON OPENED THE CHEST WITH THE PATIENT ON BYPASS, THE BRIDGE BALLOON WAS FOUND DEFLATED WITH A HIGH VOLUME OF BLOOD PRESENT IN THE CHEST (REFERENCE MDR 1721279-2021-00130 WHICH CAPTURES THE BRIDGE BALLOON WHICH WAS FOUND DEFLATED WHEN THE SURGEON OPENED THE CHEST). A SUPERIOR VENA CAVA (SVC)/RIGHT ATRIAL (RA) JUNCTION PERFORATION WAS DISCOVERED. THE SURGEON CUT AND EXTRACTED THE RA LEAD, LEAVING THE VERY TIP OF THE LEAD IN THE RIGHT ATRIUM. IT WAS CONFIRMED ON 09 JULY 2021 (BY A PHILIPS REPRESENTATIVE WHO SPOKE WITH THE PHYSICIAN) THAT THE PHYSICIAN ALSO CUT AND CAPPED THE RV LEAD''S DISTAL TIP AND COIL (WITH A PORTION OF THE LLD INSIDE THE RV LEAD AS WELL), AND THEY REMAINED IN THE PATIENT''S RIGHT VENTRICULAR- RIGHT ATRIAL AREA (REFERENCE MDR 1721279-2021-00132 WHICH CAPTURES THE PORTION OF THE LLD WHICH REMAINED IN THE RV LEAD WHEN IT WAS CUT/CAPPED BY THE PHYSICIAN). THERE IS NO INFORMATION AVAILABLE REGARDING RE-IMPLANTATION OF NEW LEADS. THE RESCUE EFFORTS WERE SUCCESSFUL AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE 16F GLIDELIGHT DEVICE WHICH WAS IN USE IN THE AREA OF INJURY AND MAY HAVE CAUSED/CONTRIBUTED TO THE SVC/RA JUNCTION PERFORATION. THERE WAS NO ALLEGED MALFUNCTION OF THE GLIDELIGHT DEVICE USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101902 SPECTRANETICS 16F GLIDELIGHT LASER SHEATH DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS MFA THE SPECTRANETICS CORPORATION 500-303 FGC20D14A 00813132020347

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R