BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX PRO

    MDR report key: 20051466 · Received August 23, 2024

    Report

    Report Number
    3007635982-2024-00211
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 12, 2024
    Report Date
    August 26, 2024
    Manufacturer
    CORDIS US. CORP
    Product Code
    LIT
    UDI-DI
    10705032059862
    PMA / PMN Number
    K112797
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    COMPLAINT CONCLUSION: AS REPORTED, DURING THE INJECTION OF A OF AN 8MM X 8CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WITH A SYRINGE, THE ¿THERAPEUTIC EFFECT WAS NOT ACHIEVED. THE DEVICE WAS REMOVED, AND THE BALLOON TIP WAS FOUND TO BE RUPTURED DURING DILATION. THE DEVICE WAS REPLACED WITH AN UNKNOWN BALLOON CATHETER, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PORTAL VEIN STENTING PROCEDURE DUE TO PORTAL VEIN OCCLUSION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE REPORTED ¿BALLOON BURST¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS, ALTHOUGH UNKNOWN, MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. HOWEVER, WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS AND WITH THE LIMITED AMOUNT OF INFORMATION PROVIDED, IT IS DIFFICULT TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT REPORTED. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE, ¿IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING. BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURE. THE RATED BURST PRESSURE IS BASED ON THE RESULTS OF IN VITRO TESTING. AT LEAST 99.9% OF THE BALLOONS (WITH A 95% CONFIDENCE), WILL NOT BURST AT OR BELOW THEIR RATED BURST PRESSURE. USE OF A PRESSURE MONITORING DEVICE IS RECOMMENDED TO PREVENT OVER PRESSURIZATION. USE ONLY THE RECOMMENDED BALLOON INFLATION MEDIUM. NEVER USE AIR OR ANY GASEOUS MEDIUM TO INFLATE THE BALLOON. PRIOR TO ANGIOPLASTY, THE CATHETER SHOULD BE EXAMINED TO VERIFY FUNCTIONALITY AND ENSURE THAT ITS SIZE AND SHAPE ARE SUITABLE FOR THE SPECIFIC PROCEDURE FOR WHICH IT IS TO BE USED.¿ THE INFORMATION AVAILABLE DOES NOT SUGGESTS A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, DURING THE INJECTION OF A OF AN 8MM X 8CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WITH A SYRINGE, THE ¿THERAPEUTIC EFFECT WAS NOT ACHIEVED. THE DEVICE WAS REMOVED, AND THE BALLOON TIP WAS FOUND TO BE RUPTURED DURING DILATION. THE DEVICE WAS REPLACED WITH AN UNKNOWN BALLOON CATHETER, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PORTAL VEIN STENTING PROCEDURE DUE TO PORTAL VEIN OCCLUSION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE HOSPITAL REPORTED THIS CASE AS AN ADVERSE EVENT TO CHINA NMPA DIRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742166 POWERFLEX PRO CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT CORDIS US. CORP 82290585 10705032059862

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female UNKNOWN BALLOON CATHETER.