BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABERX RADIANZ

    MDR report key: 20137179 · Received September 4, 2024

    Report

    Report Number
    3007635982-2024-00223
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 8, 2024
    Report Date
    September 4, 2024
    Manufacturer
    CORDIS US. CORP
    Product Code
    LIT
    UDI-DI
    20705032081327
    PMA / PMN Number
    K201377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE 4MM 6CM SABER RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED. IT WAS DELIVERED TO THE LESION AND INFLATED. HOWEVER, IT RUPTURED AT EIGHT ATM DURING ITS INITIAL INFLATION. THE PRODUCT WAS REMOVED INTACT FROM THE PATIENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THE LESION WAS MILDLY CALCIFIED, AND THE VESSEL TORTUOSITY WAS ALSO MILD. THE STENOSIS WAS COMPLETE AT 100%, AND THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE PRODUCT WAS STORED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTIES ENCOUNTERED WITH REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGES WERE OBSERVED PRIOR TO INSERTION INTO THE PATIENT. THE DEVICE WAS PREPARED AS PER THE INSTRUCTIONS FOR USE AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO RESISTANCE/FRICTION NOTED WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER, NOR WAS THERE ANY DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR CROSSING THE LESION. THE CATHETER DID NOT HAVE ANY ACUTE BENDS AND DID NOT KINK DURING USE. THE CONTRAST TO SALINE/RATIO AND THE COMPLETION DETAILS OF THE PROCEDURE WERE NOT PROVIDED. THE DEVICE WAS DISCARDED POST-PROCEDURE. 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 OF A CHRONIC TOTAL OCCLUSION WITH MILD CALCIFICATION AND 100% STENOSIS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A CHRONICALLY OCCLUDED VESSEL MAKES CROSSING INTO THE LESION DIFFICULT; IT IS LIKELY DAMAGE TO BALLOON MATERIAL OCCURRED IN THE ATTEMPT TO CROSS OR UPON INFLATION. 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.

    Description of Event or Problem · 0

    AS REPORTED, THE 4MM 6CM SABER RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED. IT WAS DELIVERED TO THE LESION AND INFLATED. HOWEVER, IT RUPTURED AT 8 ATM DURING ITS INITIAL INFLATION. THE PRODUCT WAS REMOVED INTACT FROM THE PATIENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THE PRODUCT WAS STORED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTIES ENCOUNTERED WITH REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGES WERE OBSERVED PRIOR TO INSERTION INTO THE PATIENT. THE DEVICE WAS PREPARED AS PER THE INSTRUCTIONS FOR USE AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE LESION WAS MILDLY CALCIFIED, AND THE VESSEL TORTUOSITY WAS ALSO MILD. THE STENOSIS WAS COMPLETE AT 100%, AND THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE/FRICTION NOTED WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER, NOR WAS THERE ANY DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR CROSSING THE LESION. THE CATHETER DID NOT HAVE ANY ACUTE BENDS AND DID NOT KINK DURING USE. THE CONTRAST TO SALINE/RATIO AND THE COMPLETION DETAILS OF THE PROCEDURE WERE NOT PROVIDED. THE DEVICE WAS DISCARDED POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187066 SABERX RADIANZ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT CORDIS US. CORP 82258893 20705032081327

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK.