BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX P3 PTA DILATATION CATHETER

    MDR report key: 2210263 · Received August 12, 2011

    Report

    Report Number
    9616099-2011-00639
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 14, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE POWERFLEX BALLOON CATHETER WAS INFLATED IT WAS REPORTED THAT THE SECONDARY PROFILE OF THE BALLOON WAS TOO BIG AND THUS COULD NOT BE REMOVED THROUGH THE SHEATH INTRODUCER. THE PHYSICIAN HAD TO REMOVE THE BALLOON AND THE SHEATH TOGETHER. THERE WAS NO REPORTED PATIENT INJURY. IT WAS NOTED THAT THERE WERE NO ANOMALIES NOTED ON THE OUTER BOXES OR INNER POUCHES OF THE PRODUCTS OR ON THE PRODUCTS THEMSELVES AND THAT THEY PREPPED NORMALLY. ONE NON-STERILE CATHETER POWER FLEX P3 4.0 MM X 10 CM 80 CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE BALLOON WAS INFLATED AND DEFLATED. THE BALLOON WAS OBSERVED ACCORDION-LIKE. NO OTHER ANOMALIES WERE OBSERVED IN THE RETURNED DEVICE. DIMENSIONAL ANALYSIS FOR OD PROXIMAL SEAL COULD BE PERFORMED USING THE VERNIER A 1.88 MM REQUESTED PER (B)(4), AND THE OD PROXIMAL SEAL WAS FOUND WITHIN OF SPECIFICATION WITH A MEASURE OF 1.85 MM. DIMENSIONS PROXIMAL SEAL DIAMETER 5F - 1.88 MM. SEM ANALYSIS WAS PERFORMED IN ORDER TO IDENTIFY THE CAUSE OF BALLOON ACCORDION-LIKE CONDITION. RESULTS SHOWED THAT THE BALLOON EXTERNAL SURFACE EXHIBITED EVIDENCE OF HEAVY WRINKLING. THE BALLOON EXTERNAL SURFACE EXHIBITED NO OTHER SURFACE ANOMALIES THAT COULD HAVE CAUSED THE ACCORDIONED-LIKE CONDITION. THE MARKER BANDS EXHIBITED NO ANOMALIES. THE REPORTED FAILURE REPORTED BY THE CUSTOMER WAS CONFIRMED; HOWEVER, CONTROL IS IN PLACE TO PREVENT DEFECTIVE FROM THE BALLOON ACCORDION-LIKE. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN. THE CAUSE OF THE FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER MAY HAVE BEEN CAUSED BY DEVICE INTERACTION, PROCEDURAL FACTORS, VESSEL CHARACTERISTICS AND/OR USER HANDLING.

    Description of Event or Problem · 1

    AFTER THE POWERFLEX BALLOON CATHETER WAS INFLATED, THE SECONDARY PROFILE OF THE BALLOON WAS TOO BIG AND THE BALLOONS COULD NOT BE REMOVED THROUGH THE SHEATH. THE PHYSICIAN HAD TO REMOVE THE BALLOON TOGETHER WITH THE BRITE TIP SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERFLEX P3 PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1