BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

    MDR report key: 4190401 · Received October 21, 2014

    Report

    Report Number
    9616099-2014-00669
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 30, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    LIT
    PMA / PMN Number
    K112797
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) THE POWERFLEXPRO 4 MM. X 2 CM. BALLOON CATHETER (BC) RUPTURED BEFORE REACHING NOMINAL PRESSURE DURING THE INITIAL INFLATION. THEREFORE, IT WAS REMOVED FROM THE PATIENT AND EXCHANGED FOR ANOTHER NEW BALLOON CATHETER. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS CLINICALLY USED AND IT WILL NOT BE RETURNED FOR ANALYSIS. THE TARGET LESION WAS THE ILIAC ARTERY. THE LESION WAS REPORTED TO HAVE 100% STENOSIS/CHRONIC TOTAL OCCLUSION (CTO), WAS HEAVILY CALCIFIED AND MILDLY TORTUOUS. ACCESS WAS OBTAINED USING A NON-CORDIS SHEATH. 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. THERE WAS NO REPORTED RESISTANCE/FRICTION REPORTED WHILE ADVANCING THE CATHETER THROUGH THE ROTATING HEMOSTASIS VALVE, OR GUIDING CATHETER. AN UNKNOWN INFLATION DEVICE WAS USED FOR THE PROCEDURE AND WAS USED SUBSEQUENTLY WITH OTHER DEVICES. THE RATIO OF CONTRAST TO SALINE WAS UNKNOWN. THERE WAS NO REPORTED DIFFICULTY ACCESSING THE TARGET LESION AND THE CATHETER WAS NOT EVER IN AN ACUTE BEND. THE CATHETER DID NOT KINK DURING USE. THE CATHETER WAS REMOVED EASILY FROM THE PATIENT AND WAS INTACT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF LOT 15874133 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED BALLOON BURST AT/BELOW RBP COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, VESSEL CHARACTERISTICS (CALCIFICATION, CHRONIC TOTAL OCCLUSION) MAY HAVE CONTRIBUTED TO THE REPORTED BURST. BALLOON BURST IS A WELL-KNOWN PROCEDURAL COMPLICATION DURING ANGIOPLASTY WHERE PROCEDURAL FACTORS AND VESSEL CHARACTERISTICS OFTEN CONTRIBUTE TO DAMAGE OF THE BALLOON. IN THIS CASE, NEITHER THE DHR NOR THE INFORMATION AVAILABLE SUGGESTS THAT THE REPORTED BURST COULD BE RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(6). THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. 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 POWERFLEXPRO 4 MM. X 2 CM. BALLOON CATHETER (BC) RUPTURED BEFORE REACHING NOMINAL PRESSURE DURING THE INITIAL INFLATION. THEREFORE, IT WAS REMOVED FROM THE PATIENT AND EXCHANGED FOR ANOTHER NEW BALLOON CATHETER. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS CLINICALLY USED AND IT WILL NOT BE RETURNED FOR ANALYSIS. THE TARGET LESION WAS THE ILIAC ARTERY. THE LESION WAS REPORTED TO BE: A 100% STENOSIS/CHRONIC TOTAL OCCLUSION (CTO), HEAVILY CALCIFIED AND MILDLY TORTUOUS. THE RATE OF STENOSIS WAS 100% (CTO). ACCESS WAS OBTAINED USING A NON-CORDIS SHEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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. THERE WAS NO REPORTED RESISTANCE/FRICTION REPORTED WHILE ADVANCING THE CATHETER THROUGH THE ROTATING HEMOSTASIS VALVE, OR GUIDING CATHETER. AN UNKNOWN INFLATION DEVICE WAS USED FOR THE PROCEDURE AND WAS USED SUBSEQUENTLY WITH OTHER DEVICES. THE RATIO OF CONTRAST TO SALINE WAS UNKNOWN. THERE WAS NO REPORTED DIFFICULTY ACCESSING THE TARGET LESION AND THE CATHETER WAS NOT EVER IN AN ACUTE BEND. THE CATHETER DID NOT KINK DURING USE. THE CATHETER WAS REMOVED EASILY FROM THE PATIENT AND WAS INTACT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667357 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER PTA CATHETERS (LIT) LIT CORDIS CORPORATION 4400402S 15874133

    Patients

    Seq Age Sex Outcome Treatment
    1