BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESEP OLIGON OXIMETRY CATHETERS

    MDR report key: 2834345 · Received November 15, 2012

    Report

    Report Number
    2015691-2012-18660
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQE
    PMA / PMN Number
    K060093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 0.032 GUIDEWIRE WAS RECEIVED AND APPEARED TO BE DAMAGED. THERE WERE NO OTHER COMPONENTS RETURNED. THE RETURNED 0.032" GUIDEWIRE WAS RECEIVED WITH A WELD BREAK ON THE "J" TIP END AND THE OUTER COILS HAVE BEEN STRETCHED 40CM. IT APPEARS THAT THE BEGINNING OF THE OUTER COIL HAD BEEN STRETCHED 26CM PROXIMAL OF THE "J" TIP END OF THE WIRE. THERE WERE NO MISSING SECTIONS OF THE WIRE. VISUAL EXAMINATION PERFORMED WITH (B)(4). A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. ALTHOUGH THE COMPLAINT WAS CONFIRMED, THERE WAS NO EVIDENCE OF A MANUFACTURING NONCONFORMANCE FOUND DURING THE EVALUATION. CLINICAL FACTORS MAY HAVE CONTRIBUTED TO THE DIFFICULTY EXPERIENCED. NO ACTIONS WILL BE TAKEN AT THIS TIME. EDWARDS IS CURRENTLY IN THE PROCESS OF IMPLEMENTING A NITINOL GUIDEWIRE IN THIS PRODUCT FAMILY TO FACILITATE EASIER PLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE REMOVING AFTER INSERTING THE CATHETER, THE DOCTOR NOTED THAT THE GUIDEWIRE HAD FRAYED. IT WAS FURTHER INDICATED THAT "THE FRAYED COVER" SNAGGED THE CATHETER AND BEGAN TO DISLODGE IT. THE GUIDEWIRE IS BEING RETURNED, THE CATHETER REMAINED WITH THE PATIENT. FOLLOW UP INDICATED THAT THERE WAS NO PROBLEM ACCESSING THE LUMEN OF THE VESSEL. THE WIRE WAS NOT THREADED THROUGH THE NEEDLE MULTIPLE TIMES. THERE WAS NO FRICTION FELT UNTIL THE WIRE WAS WITHDRAWN. UPON ITS WITHDRAWAL THE WIRE WAS COMPLETELY FRAYED. THERE WERE NO PATENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESEP OLIGON OXIMETRY CATHETERS CATHETER, OXIMETER, FIBEROPTIC DQE EDWARDS LIFESCIENCES, PR XA3820HCDCNL 59307434

    Patients

    Seq Age Sex Outcome Treatment
    1