BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 5402593 · Received February 1, 2016

    Report

    Report Number
    1820334-2016-00056
    Event Type
    Injury
    Date Received
    February 1, 2016
    Date of Event
    January 7, 2016
    Report Date
    January 14, 2016
    Manufacturer
    COOK INC
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). K130293. **INVESTIGATION** A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL (QC) AND A VISUAL INSPECTION WAS CONDUCTED DURING THE INVESTIGATION. A VISUAL EXAMINATION NOTED THAT THE RETURNED SHAFT LENGTH IS 144.2 CM AND THAT 7MM OF BALLOON (DISTAL TO THE PROXIMAL BALLOON BOND) IS REMAINING. IT WAS DETERMINED THAT THE CATHETER SHEARED OFF AT THE BALLOON BOND. TWO PINCHED POINTS WERE NOTICED JUST PROXIMAL TO THE PROXIMAL BALLOON BOND. PER DFMEA BALLOON BURST, COMPLIANCE, FATIGUE, TENSILE STRENGTH, AND SHEATH COMPATIBILITY VERIFICATION TESTS HAVE BEEN PERFORMED. THE BALLOON IS INSPECTED FOR WALL THICKNESS, VISUAL DEFECTS, AND PRESENCE OF CROW'S FEET. ALSO, AN INSPECTION IS PERFORMED FOR BALLOON RATED BURST PRESSURE AND TO ENSURE THE BALLOON DOES NOT BURST RADIALLY. THE DEVICE IS SHIPPED WITH AN IFU THAT DESCRIBES THE INTENDED USE, SPECIFIC ITEMS ARE ADDRESSED SUCH AS: USE OF A PRESSURE GAUGE IS RECOMMENDED TO MONITOR INFLATION PRESSURES. IF BALLOON PRESSURE IS LOST AND/OR BALLOON RUPTURE OCCURS, DEFLATE BALLOON AND REMOVE BALLOON AND SHEATH AS A UNIT. THE LABEL STATES THE RATED BURST PRESSURE IS 14ATM/BAR. PER REVIEW OF THE BALLOON REMNANT, THERE ARE NO SIGNS OF LINEAR TEARS. IT IS POSSIBLE THAT THE BALLOON RUPTURE STARTED LINEARLY AND THEN TORE OFF CIRCUMFERENTIALLY; HOWEVER, WITHOUT THE SECOND HALF OF THE BALLOON, IT IS IMPOSSIBLE TO TELL. HIGHLY CALCIFIED AREAS ARE THOUGHT TO CONTRIBUTE TO BALLOON RUPTURES AND ARE MORE LIKELY TO CONTRIBUTE TO CIRCUMFERENTIAL RUPTURES. IN THE ABSENCE OF EXTERNAL RESTRAINTS, THE BALLOON IS DESIGNED TO BURST LINEARLY. WHEN SUFFICIENTLY CONSTRICTED BY LESIONS/CALCIFICATIONS OR OTHER TORTUROUS ANATOMY, THE TEAR MAY GO CIRCUMFERENTIAL. THE USER DID NOT REPORT THAT THE AREA BEING TREATED WAS CALCIFIED, ALTHOUGH THE PROCEDURE WAS TO PLACE TWO STENTS SO THERE WAS MOST LIKELY SOMETHING CONSTRICTING THE ARTERY. A DEFINITIVE ROOT CAUSE RESULTING IN INITIAL BURST AND SUBSEQUENT SEPARATION CANNOT BE DETERMINED. WE HAVE NOTIFIED APPROPRIATE INTERNAL PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). K130293. THE EVEN IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE SURGEON WAS DOING A LEFT BRACHIAL ARTERY APPROACH THROUGH THE LEFT AND EXTERNAL ILIAC. THE LESION WAS PRE DILATED AND 2 (10MM ZILVER 518) STENTS WERE PLACED. AFTER THE THIRD INFLATION AT 8 ATM, THE ADVANCE 18 LP LOW PROFILE BALLOON WAS ADVANCED FOR POST DILATION WHEN THE BALLOON RUPTURED. THE BALLOON BECAME STUCK AND THE SURGEON WAS ABLE TO REMOVE A PORTION, LEAVING A FRAGMENT OF THE BALLOON STUCK IN THE PATIENT'S STENT. ACCESS WAS GAINED IN THE LEFT COMMON FEMORAL ARTERY AND THE SURGEON WAS ABLE TO CROSS PAST THE FRAGMENTED BALLOON AND PLACE 2 COVERED STENTS TO REESTABLISH FLOW TO THE VESSEL. THE ADDITIONAL PLACED STENTS PRESSED THE FRAGMENTED PORTION OF THE BALLOON TO THE WALL ON THE OTHER ZILVER STENTS. NO HARM WAS REPORTED TO THE PATIENT.

    Description of Event or Problem · 1

    THE SURGEON WAS DOING A LEFT BRACHIAL ARTERY APPROACH, THROUGH LEFT AND EXTERNAL ILIAC. THE LESION WAS PRE DILATED AND 2 10MM ZILVER 518 STENTS WERE PLACED. AFTER THE THIRD INFLATION AT 8 ATM'S THE ADVANCE 18 LP LOW PROFILE BALLOON WAS ADVANCED FOR POST DILATION WHEN THE BALLOON RUPTURED. THE BALLOON BECAME STUCK AND THE SURGEON WAS ABLE TO REMOVE A PORTION, LEAVING A FRAGMENT OF THE BALLOON STUCK IN THE PATIENT'S STENT. ACCESS WAS GAINED IN THE LEFT COMMON FEMORAL ARTERY AND THE SURGEON WAS ABLE TO CROSS PAST THE FRAGMENTED BALLOON AND PLACE 2 COVERED STENTS TO REESTABLISH FLOW TO THE VESSEL. THE ADDITIONAL PLACED STENTS PRESSED THE FRAGMENTED PORTION OF THE BALLOON TO THE WALL ON THE OTHER ZILVER STENTS. NO HARM WAS REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59675 ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention