BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LASER SHEATH

    MDR report key: 1744574 · Received June 30, 2010

    Report

    Report Number
    1721279-2010-00045
    Event Type
    Injury
    Date Received
    June 30, 2010
    Date of Event
    January 1, 2009
    Report Date
    June 25, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 #6 OF SIX JOURNAL ARTICLES FOUND DURING A ROUTINE CLINICAL LITERATURE REVIEW. "ENDOVASCULAR MANAGEMENT OF MULTIPLE ARTERIOVENOUS FISTULA FOLLOWING FAILED LASER-ASSISTED PACEMAKER LEAD EXTRACTION". JOURNAL: J OF VASC SURG 2010;1-4. PATIENT WAS A (B) (6). FEMALE WITH A HISTORY OF A FAILED LASER LEAD EXTRACTION AT ANOTHER INSTITUTION. PATIENT PRESENTED WITH DYSPNEA, HOARSENESS AND LEFT ARM EDEMA. UPON FURTHER EXAMINATION, A HIGH-FLOW AV FISTULA WAS DISCOVERED FROM THE LEFT SUBCLAVIAN ARTERY TO THE LEFT SUBCLAVIAN VEIN. AFTER SEVERAL SURGICAL PROCEDURES, THE PATIENT'S FISTULA WAS REPAIRED SUCCESSFULLY. THE PATIENT RECOVERED, WAS DISCHARGED AND 6MTHS POST-OPERATIVE, ONLY RESIDUAL HOARSENESS PERSISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH SLS (UNKNOWN SIZE) MFA SPECTRANETICS CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SPECTRANETICS CVX-300 LASER