BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 2013384 · Received March 8, 2011

    Report

    Report Number
    1721279-2011-00012
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED TO THE EMERGENCY ROOM APPROXIMATELY 10 DAYS PRIOR TO THE CASE WITH ACUTE SEPSIS FOLLOWING A (B)(6) 2011 CARDIAC LEAD IMPLANTATION. PATIENT WAS ADMITTED AND WAS DETERMINED NOT SUITABLE AT THE TIME FOR LEAD REMOVAL. SHE REMAINED INPATIENT RECEIVING BOTH ORAL AND IV ANTIBIOTIC THERAPY. THE PHYSICIAN CONSULTED WITH THE MEDICAL DOCTOR LM TRAINER FROM UNIVERSITY OF PENN PRE-OPERATIVELY. IT WAS DECIDED TO PROCEED WITH THE LASER LEAD REMOVAL CASE; WITH THE BACK UP OPTION OF REMOVAL WOULD BE OPEN CHEST REMOVAL. SINCE THIS WAS A KNOWN OPTION THE CT SURGEON WAS SCRUBBED IN AND ASSISTING WITH THE CASE. PATIENT WAS INTUBATED, BASELINE BP WAS 104/56, ARTERIAL LINE PLACED, AND IN-ROOM FLUOROSCOPY. MEDICAL DOCTOR PREPPED ALL 4 LEADS (RA, LV, AND RV-ICD X 2) WITH LLD-EZ AND LLD#2. BOTH THE RA AND LV LEADS (IMPLANTED (B)(6) 2011) WERE UNSCREWED AND SUCCESSFULLY REMOVED WITHOUT DIFFICULTY. MEDICAL DOCTOR BEGAN LASING WITH THE 14F SLS II, UPSIZING TO THE 16F SLS II. THE MEDICAL DOCTOR ENCOUNTERED SIGNIFICANT CALCIUM AND HAD A VERY DIFFICULT TIME REMOVING THE LV LEAD, BUT IT EVENTUALLY WAS ABLE TO EXTRACT THE LEAD. LASTLY, HE MOVED TO THE FINAL ICD LEAD BEGINNING WITH A 14F SLS II AND UPSIZING AGAIN TO 16F SLS II ENCOUNTERING THE SAME TYPE OF SEVERE FIBROSIS AND CALCIUM. AT THIS POINT THE PHYSICIANS BEGAN DISCUSSING CLOSING THE PATIENT, HAVING HER RETURN THE FOLLOWING DAY FOR OPEN CHEST PROCEDURE, WHEN THE PATIENT'S BP FELL TO A SYSTOLIC OF 80. FLUOROSCOPY NOTED A CHANGE IN CARDIAC MOVEMENT AND THE DECISION WAS MADE TO PERFORM AN EMERGENT STERNOTOMY. THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS TO REPAIR AND EXTRACT. UPON OPENING THE PATIENT A SVC PERFORATION WAS DISCOVERED, SUCCESSFULLY REPAIRED AND THE REMAINING LEAD WAS EXTRACTED. THE PATIENT'S VITALS RETURNED TO BASELINE LEVELS AND EVENTUALLY TRANSFERRED TO THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH II 16F SLS II MFA SPECTRANETICS CORPORATION 500-013 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening| R LLD#2: 518-019, LOT# UNKNOWN| LLD-EZ: 518-062, LOT# UNKNOWN| 14F SLS II: 500-012, LOT# UNKNOWN| EXCIMER LASER SYSTEM: CVX-300, SERIAL# (B)(4)