BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SABER PTA DILATATION CATHETER

    MDR report key: 4791077 · Received May 22, 2015

    Report

    Report Number
    9616099-2015-00211
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    April 27, 2015
    Report Date
    May 29, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    LIT
    PMA / PMN Number
    K971010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), THE 150 CM. SABER 6 MM. X 15 CM. BALLOON CATHETER (BC) RUPTURED AND THE BALLOON MATERIAL SHEARED OFF THE SHAFT. THE BALLOON MATERIAL WAS RECOVERED INSIDE THE UNKNOWN PROCEDURAL SHEATH. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SHEATH USED WAS A NON-CORDIS SHEATH. A P3 BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS WITHDRAWAL DIFFICULTY OF THE DEVICE FROM THE TARGET LESION AND THROUGH THE SHEATH USED. THE BC RUPTURED AT SIXTEEN ATMOSPHERES (16 ATM.) AND IT WAS NOT DURING THE INITIAL INFLATION (THE EXACT NUMBER OF INFLATIONS WAS NOT PROVIDED). THE BALLOON SEPARATION OCCURRED DURING WITHDRAWAL THROUGH THE SHEATH. THE SEPARATED PORTION CAME OUT ON THE GUIDEWIRE USED. NO ADDITIONAL INTERVENTION WAS NECESSARY TO REMOVE THE SEPARATED PORTION. THE ENTIRE SEPARATED PORTION WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE TARGET LESION WAS NOT PROVIDED BUT WAS REPORTED TO BE CALCIFIED. THE APPROACH WAS RETROGRADE. THE PRODUCT WAS RETURNED FOR ANALYSIS. ONE NON-STERILE UNIT OF SABER 6MM X 15CM 150CM BC WAS RETURNED ALONG WITH AN UNKNOWN GUIDE WIRE. PER VISUAL ANALYSIS THE BALLOON SECTION WAS SEPARATED FROM THE CATHETER AND IT WAS NOT RETURNED FOR ANALYSIS. NO OTHER ISSUES WERE FOUND. A LEAK TEST COULD NOT BE PERFORMED AS THE BALLOON WAS SEPARATED FROM THE CATHETER AND IT WAS NOT RECEIVED FOR ANALYSIS. SEM ANALYSIS SHOWS THAT THE OUTER AND INNER BODY SURFACE PRESENTED EVIDENCE OF ELONGATION AT THE SURROUNDINGS AREAS OF THE SEPARATION. ELONGATION IS A COMMON CHARACTERISTIC OF PIECES WHICH WERE STRETCHED/ PULLED UNTIL SEPARATION. STRETCHING/ PULLING COULD HAVE BEEN RELATED TO THESE SEPARATION CHARACTERISTICS. THE EVENT REPORTED BY THE CUSTOMER AS ¿BALLOON - BURST-AT/BELOW RBP (PERIPHERAL)¿ COULD NOT BE CONFIRMED SINCE THE BALLOON WAS FOUND SEPARATED AND IT WAS NOT RETURNED FOR ANALYSIS. THE EVENT REPORTED BY THE CUSTOMER AS ¿BALLOON - SEPARATED - (PERIPHERAL)¿ WAS CONFIRMED. HOWEVER, THE CAUSE OF THE BALLOON SEPARATION COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS; NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE SEPARATION EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING OR DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO PROBLEMS NOTED. THERE WERE NO KINKS OR BENDS NOTED UPON INSPECTION PRIOR TO USE. THE CONTRAST USED WAS ISOVUE AND THE RATIO OF CONTRAST TO SALINE WAS FIFTY/FIFTY. A NON-CORDIS INFLATION DEVICE WAS USED FOR THE PROCEDURE AND WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO REPORTED RESISTANCE/FRICTION REPORTED WHILE ADVANCING THE CATHETER THROUGH THE ROTATING HEMOSTASIS VALVE, OR GUIDING CATHETER. THERE WAS NO REPORTED DIFFICULTY ADVANCING THE DEVICE THROUGH THE VESSEL OR ACCESSING THE TARGET LESION AND THE CATHETER WAS NOT EVER IN AN ACUTE BEND. THE CATHETER DID NOT KINK DURING USE. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), THE 150 CM. SABER 6 MM. X 15 CM. BALLOON CATHETER (BC) RUPTURED AND THE BALLOON MATERIAL SHEARED OFF OF THE SHAFT. THE BALLOON MATERIAL WAS RECOVERED INSIDE THE UNKNOWN PROCEDURAL SHEATH. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SHEATH USED WAS A NON-CORDIS SHEATH. A P3 BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS WITHDRAWAL DIFFICULTY OF THE DEVICE FROM THE TARGET LESION AND THROUGH THE SHEATH USED. THE BC RUPTURED AT SIXTEEN ATMOSPHERES (16 ATM.) AND WAS NOT DURING THE INITIAL INFLATION (THE EXACT NUMBER OF INFLATIONS WAS NOT PROVIDED). THE BALLOON SEPARATION OCCURRED DURING WITHDRAWAL THROUGH THE SHEATH. THE SEPARATED PORTION CAME OUT ON THE GUIDEWIRE USED. NO ADDITIONAL INTERVENTION WAS NECESSARY TO REMOVE THE SEPARATED PORTION. THE ENTIRE SEPARATED PORTION WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE TARGET LESION WAS NOT PROVIDED BUT WAS REPORTED TO BE CALCIFIED. THE APPROACH WAS RETROGRADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335925 SABER PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS CORPORATION 17099692

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R BC: P3