BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH

    MDR report key: 10878418 · Received November 20, 2020

    Report

    Report Number
    1721279-2020-00236
    Event Type
    Death
    Date Received
    November 20, 2020
    Date of Event
    October 28, 2020
    Report Date
    October 28, 2020
    Manufacturer
    THE SPECTRANETICS CORPORATION
    Product Code
    DRE
    UDI-DI
    00813132022808
    PMA / PMN Number
    K161333
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6): METHOD, RESULTS AND CONCLUSIONS CODES ARE NOW POPULATED SINCE IT IS CONFIRMED THE DEVICE IS NOT BEING RETURNED FOR EVALUATION. PERFORATION OF VESSELS IS A PROCEDURAL RISK WITH USE OF THE TIGHTRAIL DEVICE SO CONCLUSIONS CODE 22 WAS CHOSEN. THE MANUFACTURER RECEIVED WORD FROM THE PHILIPS REPRESENTATIVE VIA EMAIL ON 31 DEC 2020 THAT THE TIGHTRAIL DEVICE IS NOT BEING RETURNED FOR EVALUATION. THE DEVICE WAS DISCARDED; THEREFORE THIS SUPPLEMENTAL MDR IS NOW BEING SUBMITTED SINCE THE DEVICE IS NOT BEING RETURNED TO THE MANUFACTURER AND NO DEVICE EVALUATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT UNAVAILABLE. DEVICE LOT NUMBER AND EXPIRATION DATE UNAVAILABLE. DEVICE MANUFACTURE DATE UNAVAILABLE BECAUSE LOT NUMBER UNAVAILABLE ALTHOUGH THERE WAS NO ALLEGED MALFUNCTION OF THE TIGHTRAIL DEVICE, THE DEVICE HAS REPORTEDLY BEEN RETRIEVED AND THE MANUFACTURER IS ANTICIPATING RETURN OF THE TIGHTRAIL DEVICE. THE DEVICE HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND A RIGHT ATRIAL (RA) LEAD DUE TO RV LEAD MALFUNCTION AND DUE TO PATIENT'S EJECTION FRACTION (EF) BEING >70%, IT WAS THOUGHT THAT IF THE LEADS WERE REMOVED, THAT THE PATIENT MIGHT NOT ANY LONGER NEED THEM. SPECTRANETICS LEAD LOCKING DEVICES (LLD'S) WERE PLACED WITHIN EACH LEAD TO PROVIDE TRACTION DURING LEAD REMOVAL. THE CASE BEGAN WITH THE SURGEON USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH TO EXTRACT THE RA LEAD; ULTIMATELY THE RA LEAD RELEASED, RETRACTED INTO THE GLIDELIGHT'S SHEATH, AND WAS REMOVED. SIGNIFICANT SCARRING WAS NOTED AROUND THIS LEAD, RESEMBLING A ''SLEEVE'' OF SCAR TISSUE (BOTH RA AND RV LEADS WERE IMPLANTED (B)(6) 2010). HOWEVER, WHILE CALIBRATING A 16F GLIDELIGHT DEVICE TO BEGIN WORKING ON THE RV LEAD, TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) REVEALED A GROWING EFFUSION. THE SURGEON WAS SCRUBBED IN FOR THE CASE AND PERFORMED A PARTIAL STERNOTOMY IN HOPE THAT A FULL STERNOTOMY WOULDN'T BE NEEDED, SINCE THE EFFUSION STOPPED GROWING. HOWEVER, THE DECISION WAS MADE TO PERFORM A FULL STERNOTOMY AND A PERFORATION OF THE RA WAS NOTED. REPAIR TO THE AREA WAS SUCCESSFULLY MADE. FROM THE POCKET (AND WHILE THE CHEST REMAINED OPEN), A 16F GLIDELIGHT DEVICE WAS USED TO ATTEMPT TO FREE THE RV LEAD; HOWEVER PROGRESS STALLED IN THE SUBCLAVIAN REGION DUE TO SIGNIFICANT SCARRING. THE PHYSICIAN THEN CHOSE A SPECTRANETICS 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH THAT SUCCESSFULLY MADE IT TO THE INNOMINATE REGION. HOWEVER, THE SURGEON NOTED BLEEDING FROM THE PATIENT'S CHEST AND AN INNOMINATE INJURY WAS QUICKLY DISCOVERED. THE TIGHTRAIL SUB-C WAS REMOVED. IT WAS A DIFFICULT REPAIR; IT WAS DETERMINED THAT THE PATIENT'S SAPHENOUS VEIN WOULD NOT WORK FOR REPAIR, SO THE AREA WAS REPAIRED USING BOVINE PERICARDIUM. AT THAT POINT, THE TEAM CHOSE NOT TO REMOVE THE RV LEAD, WITH THE THOUGHT THAT THERE WOULD LIKELY BE ADDITIONAL SCARRING DOWN THE RV LEAD. THE RV LEAD (WITH THE LLD REMAINING INSIDE THE LEAD) WAS CUT AND CAPPED AND LEFT WITHIN THE PATIENT. THE PHYSICIAN DID NOT ATTEMPT TO UNLOCK THE LLD IN THE RV LEAD PRIOR TO CUTTING AND CAPPING. AFTER THE PROCEDURE, THERE WAS CONCERN AS TO WHETHER OR NOT THE BOVINE PERICARDIUM PATCH WAS HOLDING; THE PATIENT WAS TRANSFERRED WHILE ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) TO A LARGER FACILITY IN (B)(6) FOR FURTHER FOLLOW UP. THE PATIENT ULTIMATELY DIED ON (B)(6) 2020. THIS REPORT CAPTURES THE INNOMINATE INJURY WHICH OCCURRED DURING USE OF THE SPECTRANETICS TIGHTRAIL DEVICE ALONG WITH THE PATIENT'S DEATH, WHICH OCCURRED TWO DAYS POST PROCEDURE. MDR 1721279-2020-00235 CAPTURES THE RA PERFORATION THAT OCCURRED WHEN THE LLD WAS PROVIDING TRACTION WITHIN THE RA LEAD, AND MDR 1721279-2020-00237 CAPTURES THE LLD WHICH WAS PRESENT IN THE RV LEAD AND WAS CUT AND CAPPED AND REMAINED IN THE PATIENT. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICE IN USE DURING THE PROCEDURE. HOWEVER, THE TIGHTRAIL DEVICE WAS REPORTEDLY RETRIEVED AFTER THE PROCEDURE AND THE MANUFACTURER IS ANTICIPATING THE RETURN OF THE DEVICE FOR EVALUATION. THE DEVICE HAS NOT YET BEEN RECEIVED AT THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340086 SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE THE SPECTRANETICS CORPORATION 560-013 00813132022808

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| H| L| R MEDTRONIC 4076 RA PACING LEAD| MEDTRONIC 6947 RV ICD LEAD| SPECTRANETICS 14F GLIDELIGHT LASER SHEATH| SPECTRANETICS 16F GLIDELIGHT LASER SHEATH| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| SPECTRANETICS LEAD LOCKING DEVICES