BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABER RX5MM25CM155

    MDR report key: 7352333 · Received March 20, 2018

    Report

    Report Number
    9616099-2018-01999
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    February 21, 2018
    Report Date
    April 20, 2018
    Manufacturer
    CORDIS CASHEL
    Product Code
    LIT
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING INFLATION OF A 5MM X 25CM155CM SABER RX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER IT RUPTURED AT ITS NOMINAL PRESSURE. THEREFORE, IT WAS REPLACED WITH A NEW BALLOON CATHETER (NON-CORDIS) TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. AN IPSILATERAL APPROACH WAS MADE. THE LESION WAS A CTO (CHRONIC TOTAL OCCLUSION) OF THE SUPERFICIAL FEMORAL ARTERY AND MODERATELY CALCIFIED. A GUIDEWIRE CROSSED THE LESION AND A PRE-DILATATION WAS PERFORMED. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER AND NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THE SAME NON-CORDIS INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL AND NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE BALLOON INFLATED NORMALLY. THE MAXIMUM INFLATION PRESSURE WAS NOT PROVIDED. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. IT WAS REMOVED EASILY FROM THE VESSEL AND THE DEVICES. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 17620006 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. 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 MODERATE CALCIFICATION AND A CHRONIC TOTAL OCCLUSION MAY HAVE CONTRIBUTED TO 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.¿ NEITHER THE PHR NOR THE INFORMATION AVAILABLE SUGGESTS A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    MANUFACTURING TELEPHONE AND FAX NUMBERS OF CORDIS CASHEL ARE RESPECTIVELY, (B)(4). (B)(6). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THE SABER DEVICE IS NOT SOLD IN THE US BUT IT IS SIMILAR TO OTHER CORDIS PTA CATHETERS SOLD IN THE US IN THE LIT CATEGORY.

    Description of Event or Problem · 1

    DURING INFLATION OF A 5MM25CM155 SABER RX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER IT RUPTURED AT ITS NOMINAL PRESSURE. THEREFORE, IT WAS REPLACED WITH A NEW BALLOON CATHETER (NON-CORDIS) TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY AND THE DEVICE WILL BE RETURNED FOR ANALYSIS. AN IPSILATERAL APPROACH WAS MADE. THE LESION WAS A CTO SUPERFICIAL FEMORAL ARTERY AND MODERATELY CALCIFIED. A GUIDEWIRE CROSSED THE LESION AND A PRE-DILATATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198629 SABER RX5MM25CM155 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER LIT CORDIS CASHEL N/A 17620006

    Patients

    Seq Age Sex Outcome Treatment
    1