BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURA STAR RX PTCA BALLOON CATHETER

    MDR report key: 2000620 · Received February 24, 2011

    Report

    Report Number
    9616099-2011-00129
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 7, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P880003/S89
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE. A DURASTAR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) BALLOON RUPTURED DURING INFLATION. INFORMATION ABOUT THE PATIENT, VESSEL CHARACTERISTICS AND INTERVENTION WAS NOT AVAILABLE. THE RATE OF STENOSIS WAS NOT REPORTED. THE COMPLAINT PRODUCT WAS DELIVERED TO THE LESION AND DURING INFLATION IT RUPTURED. ACTUAL PRESSURE USED FOR DILATION WAS NOT REPORTED. THERE WAS NO REPORTED PROBLEM ENCOUNTERED ADVANCING, TRACKING OR REMOVING THE DEVICE FROM THE PATIENT. IT IS UNKNOWN IF AN INFLATION DEVICE WAS USED. INFORMATION ABOUT THE TYPE OF CONTRAST AND SALINE RATIO USED WAS NOT REPORTED. THE PRODUCT WAS NOT RETURNED. THERE WAS NO REPORTED PATIENT INJURY. ONE NON STERILE SAKURA FIRE STAR 4.00 X 10MM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE BALLOON WAS ALREADY INFLATED. RESIDUES OF INFLATION MEDIUM WERE OBSERVED IN THE INFLATION LUMEN. A BEND WAS OBSERVED IN THE OUTER BODY AT 10CM FROM THE TIP END. NO OTHER DAMAGES WERE FOUND. PRESSURIZED WATER WAS APPLIED TO THE CATHETER USING AN INDEFLATOR, AND A LEAK WAS OBSERVED IN THE INNER BODY AND OUTER BODY. SEM RESULTS SHOWED THAT THE SHAFT PRESENTS A TEAR THAT WENT THROUGH THE WHOLE WALL THICKNESS OF THE INNER AND OUTER BODIES. THE EXACT CAUSE OF THE FAILURE MODE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER IT APPEARS THAT A POINTED OBJECT WENT THROUGH THE INNER BODY AND OUT OF THE SHAFT. THE BALLOON PRESENTED NO ANOMALIES. THE UNIT WAS RECEIVED BY THE (B)(4) TEAM, AND IT WAS CONCLUDED THAT THERE ARE CONTROLS TO DETECT THIS TYPE OF DEFECTS. 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 FAILURE (BALLOON BURST) WAS NOT CONFIRMED; HOWEVER WAS DETECTED A BURST IN THE INNER BODY AND OUTER BODY. THE EXACT CAUSE OF THE DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE FAILURE IS RELATED TO THE MANUFACTURING PROCESS. IT IS LIKELY THAT PROCEDURAL FACTORS COULD HAVE CONTRIBUTED TO THE DAMAGE FOUND ON THE BODY. CONTROLS ARE IN PLACE TO PREVENT THIS TYPE OF DAMAGES (BENTS) (B)(4).THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN. THE COMPLAINT OF BALLOON RUPTURE WAS NOT CONFIRMED ON ANALYSIS; HOWEVER, THE FAILURE MODE OF BURST INNER AND OUTER BODY WAS CONFIRMED. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE EXTREMELY LIMITED INFORMATION DOES NOT SUGGEST WHAT OTHER FACTORS MAY HAVE CONTRIBUTED TO THE CONFIRMED FAILURE MODE.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT THE BALLOON RUPTURED. THERE WAS NO PATIENT HARM. THE RETURNED PRODUCT WAS EVALUATED AND THE BALLOON PRESENTED NO ANOMALIES. THE SHAFT PRESENTS A TEAR THAT WENT THROUGH THE WHOLE WALL THICKNESS OF THE INNER AND OUTER BODIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA STAR RX PTCA BALLOON CATHETER PTCA BALLOON CATHETERS (LOX) LOX CORDIS DE MEXICO NA 15248105

    Patients

    Seq Age Sex Outcome Treatment
    1