BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX EXTREME

    MDR report key: 19809580 · Received July 23, 2024

    Report

    Report Number
    3007635982-2024-00196
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    June 27, 2024
    Report Date
    August 6, 2024
    Manufacturer
    CORDIS US. CORP
    Product Code
    LIT
    UDI-DI
    10705032001946
    PMA / PMN Number
    K032737
    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

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: B4, B5, D4, D9, G3, G6, H1, H2, H3, H6, AND H11 COMPLAINT CONCLUSION: AS REPORTED, THE BALLOON OF AN 8MM X 4CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING THE THIRD INFLATION WHICH REACHED 20 ATMOSPHERES (ATM). THE DEVICE WAS REMOVED FROM THE PATIENT AND A NEW 8MM X 4CM POWERFLEX EXTREME PTA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT AN 80% STENOSIS NEAR THE ANASTOMOSIS OF A FISTULA WHICH HAD MODERATE CALCIFICATION BUT NO SIGNS OF TORTUOSITY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS PREPPED WITH A 50/50 CONTRAST AND SALINE MIXTURE AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WAS ABLE TO BE REMOVED EASILY AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED. 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. VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS LIKELY CONTRIBUTED TO THE REPORTED EVENT AS THE DEVICE WAS INTENDED FOR A STENOSED FISTULA LESION WITH MODERATE CALCIFICATION. ARTERIOVENOUS FISTULAS ARE OFTEN SCARRED AND FIBROUS IN NATURE AND OFTEN RESISTANT TO BALLOON EXPANSION INCREASING THE LIKELIHOOD OF DAMAGE TO THE BALLOON. HOWEVER, WITHOUT THE RETURN OF THE PRODUCT FOR ANALYSIS IT IS DIFFICULT TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE ¿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, THE BALLOON OF AN 8MM X 4CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING THE THIRD INFLATION WHICH REACHED 20 ATMOSPHERES (ATM). THE DEVICE WAS REMOVED FROM THE PATIENT AND A NEW 8MM X 4CM POWERFLEX EXTREME PTA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT AN 80% STENOSIS NEAR THE ANASTOMOSIS OF A FISTULA WHICH HAD MODERATE CALCIFICATION BUT NO SIGNS OF TORTUOSITY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS PREPPED WITH A 50/50 CONTRAST AND SALINE MIXTURE AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WAS ABLE TO BE REMOVED EASILY AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED, THE BALLOON OF AN 8MM X 4CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING THE THIRD INFLATION WHICH REACHED 20 ATMOSPHERES (ATM). THE DEVICE WAS REMOVED FROM THE PATIENT AND A NEW 8MM X 4CM POWERFLEX EXTREME PTA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT AN 80% STENOSIS NEAR THE ANASTOMOSIS OF A FISTULA WHICH HAD MODERATE CALCIFICATION BUT NO SIGNS OF TORTUOSITY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS PREPPED WITH A 50/50 CONTRAST AND SALINE MIXTURE AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WAS ABLE TO BE REMOVED EASILY AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2480784 POWERFLEX EXTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT CORDIS US. CORP 82289729 10705032001946

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male ANOTHER BALLOON.