BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECHSTAR XL 6 FR PVS

    MDR report key: 201293 · Received December 11, 1998

    Report

    Report Number
    2953144-1998-00129
    Event Type
    Injury
    Date Received
    December 11, 1998
    Date of Event
    November 13, 1998
    Report Date
    November 13, 1998
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CARDIOLOGIST ATTEMPTED ARTERIOTOMY CLOSURE WITH A TACHSTAR XL 6 FR PVS DEVICE. ON NEEDLE DEPLOYMENT NO NEEDLES PRESENTED. UNDER FLUOROSCOPY IT WAS NOTED THAT THE NEEDLES HAD DEFLECTED OUTSIDE THE BARREL. NEEDLE BACK DOWN WAS UNSUCCESSFUL. THE BARREL WAS CUT AWAY TO TRY TO ACCESS THE NEEDLES, BUT THE NEEDLES COULD NOT BE RETRIEVED. THE PATIENT WAS SENT TO SURGERY FOR DEVICE REMOVAL AND SURGICAL REPAIR OF THE ARTERIOTOMY. THE CARDIOLOGIST HAD NOT BEEN AWARE THAT THE PATIENT HAD A PREVIOUS ARTERIOFEMORAL BYPASS WITH A DACRON GRAFT. REVIEW OF MANUFACTURING RECORDS FOR THIS LOT SHOWED NO MANUFACTURING OR DESIGN DEFECTS. INSPECTION OF THE RETURNED DEVICE REVEALED CLAMP MARKS ON THE SUTURE LUMENS AND EVIDENCE OF SUTURE FLOSS OF THE NEEDLE GUIDE CORE CONSISTENT WITH CONTINUED DEPLOYMENT FOLLOWING SUTURE STALL. CONSTRICTION OF THE SUTURE TUBES WOULD HAVE HAMPERED SUTURE MOVEMENT AND DEFLECTED THE NEEDLES FROM THEIR INTENDED TRACK. NEEDLE DEFLECTION WAS FURTHER ENCOURAGED BY THE PRESENCE OF THE DACRON PATCH. FURTHER ATTEMPTS AT NEEDLE DEPLOYMENT AFTER THE SUTURE STALL CAUSED THE SUTURE TO FLOSS IN THE NEEDLE GUIDE. THE FLOSSING WOULD HAVE FURTHER HAMPERED SUTURE MOVEMENT AND MAY HAVE PREVENTED A SUCCESSFUL NEEDLE BACK DOWN. THEREFORE, EVIDENCE POINTS TO A COMBINATION OF USER ERROR AND PATIENT CONDITION AS THE ROOT CAUSE FOR THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECHSTAR XL 6 FR PVS PERCUTANEOUS VASCULAR SURGICAL MGB PERCLOSE, INC. NA 3885

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention NONE REPORTED.