BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 6277431 · Received January 25, 2017

    Report

    Report Number
    1820334-2017-00103
    Event Type
    Malfunction
    Date Received
    January 25, 2017
    Date of Event
    December 30, 2016
    Report Date
    April 18, 2017
    Manufacturer
    COOK INC
    Product Code
    LIT
    UDI-DI
    10827002343280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K130293. INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, AND DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE WAS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT DESCRIBES THE INTENDED USE. THE IFU STATES ¿DO NOT EXCEED RATED BURST PRESSURE. RUPTURE OF BALLOON MAY OCCUR. OVER-INFLATION MAY CAUSE RUPTURE OF THE BALLOON, WITH RESULTANT DAMAGE TO THE VESSEL WALL. THE BALLOON IS CONSTRUCTED OF A HEAT SENSITIVE MATERIAL. DO NOT HEAT OR ATTEMPT TO SHAPE THE CATHETER TIP. CHOOSE A BALLOON APPROPRIATE TO LESION AND VESSEL DIAMETER. UPON REMOVAL FROM PACKAGE, INSPECT THE CATHETER TO ENSURE NO DAMAGE HAS OCCURRED DURING SHIPPING. IF RESISTANCE IS MET WHILE ADVANCING THE BALLOON DILATION CATHETER, DETERMINE THE CAUSE AND PROCEED WITH CAUTION. IF BALLOON PRESSURE IS LOT AND/OR BALLOON RUPTURE OCCURS, DEFLATE BALLOON AND SHEATH AS A UNIT.¿ A REVIEW OF THE COMPLAINT HISTORY WAS PERFORMED AND TWO NONCONFORMANCE WERE NOTED. THE NONCONFORMANCE WERE NOT RELATED TO THIS COMPLAINT FAILURE. VISUAL INSPECTION: ONE USED DEVICE WAS RETURNED TO ASSIST IN THE INVESTIGATION. IT WAS DISCOVERED THAT THE BALLOON WAS CIRCUMFERENTIALLY RUPTURED AND THE TIP OF THE SHAFT MATERIAL WAS STRETCHED TO 5 CENTIMETERS. BOTH MARKER BANDS WERE PRESENT. MICROSCOPIC INSPECTION DID NOT REVEAL ANY ABNORMALITIES OR DEFECTS IN THE BALLOON MATERIAL. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT HAD A PREEXISTING CONDITION OF PERIPHERAL ARTERIAL OCCLUSIVE DISEASE (NARROWING OR HARDENING OF THE ARTERIES CAUSING DECREASED BLOOD FLOW) WITH A MODERATELY CALCIFIED, NON TORTUOUS LESION. CALCIFICATIONS CAN HAVE UNEXPECTED SHARP PROTRUSIONS WHICH CAN DAMAGE THE BALLOON AND CONTRIBUTE TO RUPTURE AND/OR TEAR. IT WAS CONFIRMED THAT THE BALLOON WAS RUPTURED CIRCUMFERENTIALLY. THE PTA4-18 BALLOONS ARE DESIGNED TO BURST LONGITUDINALLY (LINEARLY), WHICH REDUCES THE RISK OF THE BALLOON AND/OR CATHETER SEPARATING WHEN THE DEVICE IS WITHDRAWN. A CIRCUMFERENTIAL BURST CAUSES A MORE CHALLENGING BALLOON RE WRAP AT THE TIME OF REMOVAL. WITH THE EVIDENCE PROVIDED, IT IS PROBABLE TO CONCLUDE THAT PATIENTS PREEXISTING CONDITION CONTRIBUTED TO THE DEVICE FAILURE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS REPORTED TO CUSTOMER SERVICE BY A FOREIGN DISTRIBUTOR. IT WAS ALLEGED A BALLOON RUPTURED AT 6 ATM DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AT THE DISTAL SUPERFICIAL FEMOROPOPLITEAL ARTERY (SFA) LOCATION. REPORTEDLY THE BALLOON WAS REMOVED WITHOUT ANY PROBLEMS. THE REPORTER INDICATED THE PATIENTS LESION WAS MODERATELY CALCIFIED BUT NOT TORTUOUS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59573 ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INC N/A 10827002343280

    Patients

    Seq Age Sex Outcome Treatment
    1