BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUICK-CROSS SUPPORT CATHETER

    MDR report key: 1174584 · Received September 17, 2008

    Report

    Report Number
    1721279-2008-00026
    Event Type
    Other
    Date Received
    September 17, 2008
    Date of Event
    January 16, 2008
    Report Date
    August 5, 2008
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    DQO
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: THE LLDS USED IN THE CASE HAVE BEEN RETAINED BY THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT AND WILL NOT RETURN THEM TO SPECTRANETICS. WE CANNOT COMPLETE FAILURE ANALYSIS TO CONCLUSION WITHOUT THE DEVICE. THE PHYSICIAN REPORTED THAT HE COULD NOT EXPLAIN WHY THE DEVICE TRANSECTED.

    Description of Event or Problem · 1

    CLINICAL HISTORY: ADMITTED FOR SEVERE PVD (PERIPHERAL VASCULAR DISEASE) PROCEDURE: FOX HOLLOW ATHERECTOMY OF THE LEFT SUPERFICIAL FEMORAL ARTERY ON THE LEFT POPLITEAL ARTERY, DIAMONDBACK 360 ATHERECTOMY OF THE POSTERIOR TIBIAL ARTERY. PHYSICIAN FOUND IT DIFFICULT TO REMOVE THE DEVICE, THE DEVICE STRETCHED AND TRANSECTED AT THE AORTIC BIFURCATION FINDING THAT THE DISTAL TIP OF THE QUICK-CROSS WAS MISSING AFTER REMOVING DEVICE FROM THE PATIENT. THE TIP WAS FOUND AND SUCCESSFULLY RETRIEVED FROM THE PATIENT. PATIENT OUTCOME: THE PATIENT HAD NO REPORTED CLINICAL EFFECTS FROM THIS INCIDENT. DISPOSITION AT DISCHARGE WAS STABLE STATUS. THE REPORT WAS DELAYED WHILE ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CASE. SPECTRANETICS WILL SUBMIT A FOLLOW-UP REPORT AS THE INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK-CROSS SUPPORT CATHETER QUICK-CROSS DQO SPECTRANETICS CORP. 518-037 M204518037018

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other SPECTRANETICS LASER