BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH

    MDR report key: 6115403 · Received November 19, 2016

    Report

    Report Number
    1721279-2016-00175
    Event Type
    Injury
    Date Received
    November 19, 2016
    Date of Event
    October 28, 2016
    Report Date
    October 28, 2016
    Manufacturer
    SPECTRANETICS
    Product Code
    MFA
    PMA / PMN Number
    K142546
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE 510K NUMBER HAS BEEN CORRECTED TO REFLECT THE MOST CURRENT AND UP TO DATE NUMBER, AS OF THE DATE OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    THIS (B)(6) MALE PRESENTED FOR EXTRACTION OF ONE (1) RV CARDIAC LEAD (SJM 1581), DUE TO CIED SYSTEM/POCKET INFECTION WITH A 1.5 CM VEGETATION ON THE LEAD. THE PATIENT HAS A HISTORY OF CARDIOMYOPATHY AND HYPERTENSION. PRE-OP LABS; BUN: 11 (NML 8 ¿ 20MG/DL), CREATININE: 0.93 (NML 0.8-1.2MG/DL). THE LEAD WAS PREPPED WITH A SPECTRANETICS LEAD LOCKING DEVICE. A 14FR SPECTRANETICS GLIDELIGHT LASER SHEATH WAS INSERTED AND USED SUCCESSFULLY WITH A TEFLON OUTER SHEATH UP TO THE SVC COIL. THE MD SWITCHED TO A 13FR TIGHTRAIL DUE TO SUSPICION OF CALCIUM AND THE LEAD FAILING TO RETRACT WITH CONSIDERABLE TENSION. THE TIGHTRAIL MOVED PAST THE SVC COIL AND THEN TO THE PROXIMAL RV COIL. WHEN ATTEMPTING TO EXTRACT THE TIGHTRAIL FROM THE LEAD,IT WAS STUCK. THE MANDREL OF THE LLD BROKE AFTER USE OF HEMOSTATS FOR THE TRACTION PLATFORM. ATTEMPTS TO RETRACT THE LEAD WERE UNSUCCESSFUL AND THE PATIENTS¿ ARTERIAL BLOOD PRESSURE WAS NOT TOLERATING THESE TECHNIQUES. THE HANDLE OF THE TIGHTRAIL WAS CUT WITHOUT RETRACTION OF THE LEAD. THE PHYSICIAN ELECTED TO SUMMON THE CARDIAC SURGEON TO PERFORM AN OPEN CHEST PROCEDURE WITH THE PATIENT ON BYPASS TO EXTRACT THE LEAD. THE OPEN CHEST PROCEDURE WAS PERFORMED THROUGH MEDIAL STERNOTOMY AND THE PATIENT WAS PLACED ON BYPASS. THIS PROCEDURE WAS SUCCESSFUL AND THE PATIENT SURVIVED THE INTERVENTION. A REPORT IS FILED AGAINST THE SPECTRANETICS LEAD LOCKING DEVICE (LLD), 1721279-2016-00176.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766145 SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH TIGHTRAIL MFA SPECTRANETICS 545-513 FRJ16D05A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R CARDIAC LEAD: SJM 1581 (IMPL. 156 MOS.)| SPECTRANETICS CVX-300 LASER SYSTEM| SPECTRANETICS GLIDELIGHT LASER SHEATH| SPECTRANETICS LEAD LOCKING DEVICE