BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX P3 PTA DILATATION CATHETER

    MDR report key: 1881444 · Received October 25, 2010

    Report

    Report Number
    9610978-2010-00209
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 28, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE NON STERILE UNIT POWERFLEX P3 F5 6.0 MM X 4 CM AND 80 CM OF LENGTH WAS RECEIVED COILED INSIDE A PLASTIC BAG. DRY BLOOD RESIDUES WERE NOTED IN THE BALLOON AND HUB. A RADIAL BALLOON CUT WAS OBSERVED, THE BALLOON DISTAL END WAS SEPARATED FROM TIP. THE BALLOON APPEARS AS IF IT HAS BEEN INFLATED AND DEFLATED, BALLOON MATERIAL RESIDUES WERE OBSERVED OVER THE INNER BODY NEAR TO TIP. BOTH MARKER BANDS WERE OBSERVED ATTACHED TO UNIT. FUNCTIONAL ANALYSIS WAS NOT PERFORMED SINCE BALLOON DISTAL END WAS COMPLETELY SEPARATED FROM TIP. A SCANNING ELECTRON MICROSCOPE ANALYSIS WAS PERFORMED TO THE BALLOON OF THE RECEIVED UNIT, RESULTS INDICATES THAT PROXIMAL SECTION OF THE BALLOON EXTERNAL SURFACE EXHIBITED EVIDENCE OF SEVERE WRINKLING AND MINIMAL SPLITS. THE PROXIMAL SECTION OF THE BALLOON INTERNAL SURFACE EXHIBITED EVIDENCE OF WRINKLING. THE DISTAL SECTION OF THE BALLOON EXTERNAL SURFACE EXHIBITED EVIDENCE OF WRINKLING AND SEVERE SPLITS. MARKER BAND MOVEMENT WAS NOTED DURING ANALYSIS, EVIDENCE OF ELONGATION IS OBSERVED IN THE INNER SHAFT; THE CAUSE OF THE MOVED MARKER BAND COULD NOT BE DETERMINED. THIS BALLOON FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED COMPLAINT WAS CONFIRMED; HOWEVER, THE EXACT CAUSE OF THE FAILURE COULD NOT BE DETERMINED. MARKER BAND MOVEMENT NOTED DURING SEM ANALYSIS COULD BE CAUSED BY NOTED ELONGATION IN THE INNER SHAFT. CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE BALLOONS FROM LEAVING THE FACILITY. NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURE EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN; GIVEN THAT, THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. IT APPEARS THAT THE BALLOON BURST MAY HAVE BEEN THE REASON THAT DIFFICULTY WAS ENCOUNTERED WHILE ATTEMPTING TO REMOVE THE BALLOON FROM THE PATIENT. THE BALLOON MAY HAVE CAUGHT ON THE CATHETER RESULTING IN ELONGATION AND SEPARATION OF PART OF THE BALLOON MATERIAL. THE BALLOON BURST MAY HAVE BEEN DUE TO VESSEL CHARACTERISTICS. HOWEVER, WITHOUT RETURN OF FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED.

    Description of Event or Problem · 1

    THE DISTAL END OF BALLOON MATERIAL TORE OFF THE SHAFT OF THE BALLOON, JUST PROXIMAL TO THE DISTAL BALLOON MARKER, MAKING IT DIFFICULT TO REMOVE FROM THE PATIENT. IT WAS EVENTUALLY REMOVED SAFELY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING AND NO OTHER DAMAGE WAS NOTED PRIOR TO USE. THE DEVICE PREPPED NORMALLY. A 40/60 CONTRAST-SALINE RATION WAS USED. A MERIT MEDICAL INDEFLATOR WAS USED AND USED SUCCESSFULLY WITH OTHER DEVICES. THE LESION WAS CALCIFIED AND TORTUOUS. STENOSIS WAS 50%. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON OR CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BALLOON. THE BALLOON INFLATED NORMALLY. THE BALLOON BURST AT 12ATM. THERE WAS DIFFICULTY REMOVING THE DEVICE FROM THE GUIDE CATHETER, SHEATH, AND RHV. TO REMOVE THE BALLOON, THE WIRE WAS REMOVED. A TERUMO DESTINATION 6X45 SHEATH WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERFLEX P3 PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA R0808536

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO DESTINATION 6X45 SHEATH