BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABERX RADIANZ

    MDR report key: 20333224 · Received September 30, 2024

    Report

    Report Number
    3007635982-2024-00238
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    July 16, 2024
    Report Date
    October 7, 2024
    Manufacturer
    CORDIS US. CORP
    Product Code
    LIT
    UDI-DI
    20705032081754
    PMA / PMN Number
    K201377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: B4, G3, G6, H1, H2, H3, H6, AND H11 COMPLAINT CONCLUSION: AS REPORTED, THE BALLOON OF A 6MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 5 ATMOSPHERES (ATM). A NEW SABERX RADIANZ PTA BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A COMMON ILIAC ARTERY WHICH HAD SEVERE CALCIFICATION. A TRANS-RADIAL APPROACH WAS USED. AN UNKNOWN GUIDEWIRE WAS CROSSED THE LESION PRIOR TO THE USE OF THE SABERX PTA BALLOON CATHETER. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. 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. THE REPORTED SEVERE CALCIFICATION OF THE COMMON ILIAC ARTERY MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; IT IS LIKELY TO HAVE CAUSED DAMAGE TO THE BALLOON MATERIAL THAT LED TO ITS RUPTURE. HOWEVER, WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS DIFFICULT TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. ACCORDING TO THE WARNINGS IN THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE, ¿PRIOR TO ANGIOPLASTY, THE CATHETER SHOULD BE EXAMINED TO VERIFY FUNCTIONALITY AND INTEGRITY, AND ENSURE THAT ITS SIZE AND SHAPE ARE SUITABLE FOR THE SPECIFIC PROCEDURE FOR WHICH IT IS TO BE USED. DO NOT USE IF PRODUCT DAMAGE IS SUSPECTED OR EVIDENT. TO REDUCE THE POTENTIAL FOR VESSEL DAMAGE OR THE RISK OF DISLODGEMENT OF PARTICLES IT IS VERY IMPORTANT THAT THE INFLATED DIAMETER OF THE BALLOON SHOULD APPROXIMATE THE DIAMETER OF THE VESSEL JUST PROXIMAL AND DISTAL TO THE LESION. THE BALLOON DIMENSIONS ARE PRINTED ON THE PRODUCT LABEL. THE COMPLIANCE TABLE INCORPORATED WITH THE PRODUCT SHOWS HOW BALLOON DIAMETER INCREASES AS PRESSURE INCREASES. DO NOT EXCEED THE RATED BURST PRESSURE RECOMMENDED ON THE LABEL. 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. PRESSURE IN EXCESS OF THE RATED BURST PRESSURE CAN CAUSE BALLOON RUPTURE AND POTENTIAL INABILITY TO WITHDRAW THE CATHETER THROUGH THE INTRODUCER SHEATH. BALLOON RUPTURE CAN CAUSE VESSEL DAMAGE AND THE NEED FOR ADDITIONAL INTERVENTION. USE ONLY THE RECOMMENDED BALLOON INFLATION MEDIUM (A 50/50 MIXTURE BY VOLUME OF CONTRAST MEDIUM AND NORMAL SALINE). NEVER USE AIR OR ANY GASEOUS MEDIUM TO INFLATE THE BALLOON.¿ THE INFORMATION AVAILABLE DOES NOT SUGGEST A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    AS REPORTED, THE BALLOON OF A 6MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 5 ATMOSPHERES (ATM). A NEW SABERX RADIANZ PTA BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A COMMON ILIAC ARTERY WHICH HAD SEVERE CALCIFICATION. A TRANS-RADIAL APPROACH WAS USED. AN UNKNOWN GUIDEWIRE WAS CROSSED THE LESION PRIOR TO THE USE OF THE SABERX PTA BALLOON CATHETER. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2582607 SABERX RADIANZ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT CORDIS US. CORP 82307511 20705032081754

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SABERX RADIANZ PTA BALLOON CATHETER.| UNKNOWN GUIDEWIRE.