BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABER 2MM2CM 90

    MDR report key: 7911767 · Received September 26, 2018

    Report

    Report Number
    9616099-2018-02416
    Event Type
    Malfunction
    Date Received
    September 26, 2018
    Date of Event
    September 4, 2018
    Report Date
    October 3, 2018
    Manufacturer
    CORDIS CASHEL
    Product Code
    LIT
    PMA / PMN Number
    K971010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS NOT RETURNED DUE TO SUSPICION OF INFECTIOUS DISEASE. IT WAS ALSO USED FOR A CHRONIC TOTAL OCCLUSION. THE ACCESS SITE WAS THE COMMON FEMORAL ARTERY. THE CONCOMITANT DEVICES USED SUCH WERE A GUIDING SHEATH (PARENT/MEDIKIT), A GUIDEWIRE (VASSALLO FLOPPY/ FILMEC). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, 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 (I.E. MAINTAIN NEGATIVE PRESSURE). THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS 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 DID NOT INFLATE, AND THE CATHETER DID NOT KINK WHILE BEING USED. THE BALLOON CATHETER WAS REMOVED EASILY. CONCLUSION: AFTER A 2X20MM 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INSERTED AND INFLATED AT THE LESION IN THE SUPERFICIAL FEMORAL ARTERY, IT RUPTURED. THEREFORE, IT WAS REPLACED WITH A NEW BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS NOT RETURNED DUE TO SUSPICION OF INFECTIOUS DISEASE. IT WAS ALSO USED FOR A CHRONIC TOTAL OCCLUSION. THE ACCESS SITE WAS THE COMMON FEMORAL ARTERY. THE CONCOMITANT DEVICES USED SUCH WERE A COMPETITOR GUIDING SHEATH, A COMPETITOR GUIDEWIRE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, 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 (I.E. MAINTAIN NEGATIVE PRESSURE). THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS 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 DID NOT INFLATE, AND THE CATHETER DID NOT KINK WHILE BEING USED. THE BALLOON CATHETER WAS REMOVED EASILY. THE DEVICE WAS NOT RETURNED FOR ANALYSIS DUE TO A SUSPICION THAT THE PATIENT HAD AN INFECTIOUS DISEASE. A DEVICE HISTORY RECORD (DHR) REVIEW OF LOT: 17514481 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 OF THE BURST COULD NOT BE DETERMINED. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, VESSEL CHARACTERISTICS (CTO) AND PROCEDURAL/HANDLING FACTORS HAVE CONTRIBUTED TO THE REPORTED EVENT SINCE CALCIFIED/RESISTANT LESIONS CAN CAUSE DAMAGE TO A BALLOON. ACCORDING TO THE INSTRUCTIONS FOR USE, WHICH IS NOT INTENDED AS A MITIGATION, ¿THE RATED BURST PRESSURE IS BASED ON THE RESULT OF IN VITRO TESTING. AT LEAST 99.9% OF THE BALLOONS (WITH A 95% CONFIDENCE LEVEL) WILL NOT BURST AT OR BELOW THEIR RATED BURST PRESSURE. USE OF A PRESSURE MONITORING DEVICE IS RECOMMENDED TO PREVENT OVER PRESSURIZATION. PRIOR TO ANGIOPLASTY, THE CATHETER SHOULD BE EXAMINED TO VERIFY FUNCTIONALITY AND ENSURE THAT ITS SIZE AND SHAPE ARE SUITABLE FOR THE SPECIFIC PROCEDURE FOR WHICH IT IS TO BE USED.¿ NEITHER THE DHR REVIEW 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.

    Description of Event or Problem · 1

    AFTER A 2MM2CM 90 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INSERTED AND INFLATED AT THE LESION IN THE SUPERFICIAL FEMORAL ARTERY, IT RUPTURED. THEREFORE, IT WAS REPLACED WITH A NEW BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY AND THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753706 SABER 2MM2CM 90 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER LIT CORDIS CASHEL N/A 17514481

    Patients

    Seq Age Sex Outcome Treatment
    1