BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABER

    MDR report key: 20256833 · Received September 19, 2024

    Report

    Report Number
    3007635982-2024-00229
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    September 3, 2024
    Report Date
    September 19, 2024
    Manufacturer
    CORDIS US. CORP
    Product Code
    LIT
    UDI-DI
    20705032069493
    PMA / PMN Number
    K971010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONCLUSION: AS REPORTED, THE BALLOON OF A 4MM X 20CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS UNABLE TO HOLD PRESSURE. AFTER REMOVING THE DEVICE, THE DEVICE WAS FLUSHED, AND THE BALLOON WAS FOUND TO HAVE A PIN HOLE IN IT. A NEW 4MM X 15CM SABER PTA BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITHOUT ANY DIFFICULTY IN REMOVING THE STERILE PACKAGING COMPONENTS. DURING PREPARATION, THE DEVICE SUCCESSFULLY MAINTAINED NEGATIVE PRESSURE. THE TARGET VESSEL FOR THE PROCEDURE WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE CHARACTERISTICS OF THE TARGET SITE VESSEL INCLUDED SEVERE CALCIFICATION, WITH NO TORTUOSITY, AND A STENOSIS PERCENTAGE OF 75%. THE REPORTED ¿BALLOON FRAYED/SPLIT/TORN¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. THE REPORTED SEVERE CALCIFICATION AND SEVERE STENOSIS OF THE SUPERFICIAL FEMORAL ARTERY MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; IT IS LIKELY TO HAVE CAUSED DAMAGE TO THE BALLOON MATERIAL THAT LED TO THE PINHOLE REPORTED. 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. 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 BALLOON OF A 4MM X 20CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS UNABLE TO HOLD PRESSURE. AFTER REMOVING THE DEVICE, THE DEVICE WAS FLUSHED, AND THE BALLOON WAS FOUND TO HAVE A PIN HOLE IN IT. A NEW 4MM X 15CM SABER PTA BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITHOUT ANY DIFFICULTY IN REMOVING THE STERILE PACKAGING COMPONENTS. DURING PREPARATION, THE DEVICE SUCCESSFULLY MAINTAINED NEGATIVE PRESSURE. THE TARGET VESSEL FOR THE PROCEDURE WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE CHARACTERISTICS OF THE TARGET SITE VESSEL INCLUDED SEVERE CALCIFICATION, WITH NO TORTUOSITY, AND A STENOSIS PERCENTAGE OF 75%. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1672449 SABER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT CORDIS US. CORP 82309674 20705032069493

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female 4MM X 15CM SABER PTA BALLOON CATHETER