BEUDAMED
    FDA Adverse Event Other Summary report: N

    12F AND 16F SPECTRANETICS LASER SHEATH

    MDR report key: 1295765 · Received November 24, 2008

    Report

    Report Number
    1721279-2008-00046
    Event Type
    Other
    Date Received
    November 24, 2008
    Report Date
    November 24, 2008
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT OUTCOME: SVC TEAR. SUCCESSFULLY REPAIRED AND PT WAS TRANSFERRED TO THE ICU AND LATER DISCHARGED HOME. FAILURE ANALYSIS: THERE WERE NO DEVICES RETURNED FROM THIS CASE FOR FAILURE ANALYSIS. THERE IS NO INDICATION THAT THE EVENT WAS CAUSED BY A MALFUNCTION OF THE SPNC DEVICE. THE SPNC SALES REPRESENTATIVE IS ATTEMPTING TO GATHER A MORE DETAILED EXPLANATION OF THE CASE. UPON OBTAINING THIS INFORMATION, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CLINICAL HISTORY: PT IS A (B)(6), FEMALE OF AN UNKNOWN WEIGHT WHO UNDERWENT A LEFT-SIDED LEAD REMOVAL. PROCEDURE: ON (B)(6)2008, DR. (B)(6) ALERTED THE SPECTRANETICS REPRESENTATIVE TO A CASE THAT WAS PERFORMED "WITHIN THE LAST FEW WEEKS" BUT WAS UNSURE OF THE EXACT DATE OF THE PROCEDURE OR MANY OF THE DETAILS. DR. (B)(6) DESCRIBED THE PT AS A (B)(6) FEMALE THAT "EXPERIENCED AN SVC TEAR, WAS TAKEN TO THE OR AND THE REPAIR WAS MADE; PATIENT SURVIVED INTACT." DR. (B)(6) BEGAN THE LEAD REMOVAL PROCEDURE WITH A 12F SLS THEN UPSIZED TO A 16F SLS. THE PT'S BLOOD PRESSURE DROPPED OVER A 15 MINUTE TIME PERIOD AND ULTIMATELY A THORACTOMY WAS PERFORMED. AN ARTERIAL LINE WAS UTILIZED DURING THE CASE, BUT FLUOROSCOPY WAS NOTE. THE PHYSICIAN DID STATE HE DID NOT FEEL THAT THE SPECTRANETICS LASER OR LASER SHEATHS HAD ANYTHING TO DO WITH THE PT'S SVC TEAR. DR. (B)(6) HAS PERFORMED OVER 400 LASER CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12F AND 16F SPECTRANETICS LASER SHEATH 12F / 16F SLS MFA SPECTRANETICS CORP. 500-001 / 500-013 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention SPECTRANETICS CVX-300 LASER