BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABERX RADIANZ

    MDR report key: 22814620 · Received August 15, 2025

    Report

    Report Number
    3007635982-2025-00173
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Date of Event
    July 22, 2025
    Report Date
    August 20, 2025
    Manufacturer
    CORDIS US. CORP
    Product Code
    LIT
    UDI-DI
    20705032081741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT 82307517 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED EVENT. 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, G3, G6, H1, H2, H3, H6, AND H11. COMPLAINT CONCLUSION: AS REPORTED, AN 8MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING ITS FIRST INFLATION TO 8 ATMOSPHERES (ATM). A NON-CORDIS 8MM X 4CM DEVICE WAS USED AS A REPLACEMENT. AN UNKNOWN SMART STENT WAS IMPLANTED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A TRANS-RADIAL INTERVENTION (TRI) OF THE ILIAC VESSEL. A BRITE TIP RADIANZ CATHETER SHEATH INTRODUCER (CSI) WAS USED TO PASS AN UNKNOWN .014 GUIDEWIRE WHICH WAS FOLLOWED BY INTRAVASCULAR ULTRASOUND (IVUS). THE SABERX RADIANZ PTA BALLOON CATHETER WAS BEING USED FOR PRE-DILATION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS UNAVAILABLE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT 82307517 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED EVENT. BASED ON THE LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT ¿BALLOON BURST AT/BELOW RBP¿ COULD NOT BE EVALUATED. WITH THE LIMITED INFORMATION PROVIDED, WITHOUT THE RETURN OF THE DEVICE, AND WITH NO PROCEDURAL FILMS, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. 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.¿ BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE IS NO INDICATION TO SUGGEST THAT THE REPORTED INCIDENT COULD BE RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE UNITS. NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, AN 8 MM X 4 CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING ITS FIRST INFLATION TO 8 ATMOSPHERES (ATM). A NON-CORDIS 8 MM X 4 CM DEVICE WAS USED AS A REPLACEMENT. AN UNKNOWN SMART STENT WAS IMPLANTED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A TRANS-RADIAL INTERVENTION (TRI) OF THE ILIAC VESSEL. A BRITE TIP RADIANZ CATHETER SHEATH INTRODUCER (CSI) WAS USED TO PASS AN UNKNOWN .014 GUIDEWIRE WHICH WAS FOLLOWED BY INTRAVASCULAR ULTRASOUND (IVUS). THE SABERX RADIANZ PTA BALLOON CATHETER WAS BEING USED FOR PRE-DILATION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS UNAVAILABLE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2726786 SABERX RADIANZ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT CORDIS US. CORP 82307517 20705032081741

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BRIT TIP RADIANZ CSI.| NON-CORDIS 8 MM X 4 CM DEVICE.| UNKNOWN .014 GUIDEWIRE.| UNKNOWN SMART STENT.| VASSALLO SUPPORT.