BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-CATH HEMO. INT., 8.5F, SWARTZ SL1,TRANS.

    MDR report key: 1842540 · Received September 1, 2010

    Report

    Report Number
    3005188751-2010-00084
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    PMA / PMN Number
    K061015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION OF THE RETURNED CATHETER REVEALED DAMGE TO THE DISTAL TIP END OF THE SHEATH, WHICH WAS CONSISTENT WITH ENCOUNTERING SOME FORM OF RESISTANCE ALONG THE SHEATH TIP CIRCUMFERENCE. THE DISTAL 2" OF THE DILATOR TIP WAS CROSS SECTIONED OPEN, WHICH REVEALED NO EVIDENCE OF SKIVING OR ANY OBVIOUS SCRATCHES ALONG THE INNER WALL OF THE DILATOR. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED WITH LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE CAUSE FOR THE REPORTED EVENT REMAINS UNK. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: 09/01/2010. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(4) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE NEEDLE WAS INSERTED INTO THE SHEATH, IT SCRATCHED THE INNER LUMEN OF THE DILATOR. THE PHYSICIAN REMOVED AND REPLACED THE NEEDLE AND SHEATH AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT CONSEQUENCES TO THE PT. A SMALL SLIT WAS NOTICED IN THE TIP OF THE SHEATH AFTER IT WAS REMOVED FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-CATH HEMO. INT., 8.5F, SWARTZ SL1,TRANS. FAST-CATH TRANSSEPTAL DYB ST. JUDE MEDICAL, AF DIVISION 406849 2871304

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR