BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LASER SHEATH

    MDR report key: 1744575 · Received June 30, 2010

    Report

    Report Number
    1721279-2010-00040
    Event Type
    Injury
    Date Received
    June 30, 2010
    Date of Event
    January 1, 1998
    Report Date
    June 25, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VIEWS AND CONCLUSIONS PRESENTED IN THIS JOURNAL ARTICLE DO NOT NECESSARILY REFLECT THOSE OF THE SPECTRANETICS CORPORATION. NO DEVICES FROM THE CASE WERE RETURNED FOR INVESTIGATIVE ANALYSIS, NOR WERE ANY ADDITIONAL CASE DETAILS PROVIDED FOR AN INTERNAL EVALUATION.

    Description of Event or Problem · 1

    THIS IS ONE OF SIX JOURNAL ARTICLES FOUND DURING A ROUTINE CLINICAL LITERATURE REVIEW. "ARTERIOVENOUS FISTULA AFTER INJURY OF THE LEFT INTERNAL MAMMARY ARTERY DURING EXTRACTION OF PACEMAKER LEADS WITH A LASER SHEATH". JOURNAL: PACE 1999;22:833-834. (B)(6). FEMALE PRESENTING WITH A MALFUNCTIONING LEAD. PT HAD A SUBCUTANEOUSLY IMPLANTED DUAL CHAMBERED PACEMAKER IN THE LEFT PECTORAL AREA CONNECTED WITH BIPOLAR LEADS (RV & RA). MD LASED AND SUCCESSFULLY REMOVED THE VENTRICLE LEAD WITH THE 14F SLS. MOVING NEXT TO THE DISTAL LEAD, AGAIN USING THE 14F SLS WITH THE OUTER SHEATH, DISLODGED THE ATRIAL LEAD WITH COUNTERTRACTION. POST-OPERATIVELY, THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE. ANGIOGRAPHY SHOWED A SEVERED LEFT MAMMARY ARTERY. INJURY WAS SUCCESSFULLY REPAIRED. THE PATIENT RECOVERED AND WAS DISCHARGED WITHOUT FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH 14F SLS MFA SPECTRANETICS CORP. 500-012 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention MICROCOIL' COOK INC.| SPECTRANETICS CVX-300 LASER,