BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 8358149 · Received February 21, 2019

    Report

    Report Number
    1820334-2019-00449
    Event Type
    Malfunction
    Date Received
    February 21, 2019
    Date of Event
    February 12, 2019
    Report Date
    May 2, 2019
    Manufacturer
    COOK INC
    Product Code
    LIT
    UDI-DI
    10827002309644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, OR UNAVAILABLE. INVESTIGATION - EVALUATION A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DEVICE HISTORY RECORD, FUNCTIONAL TESTING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. RETURN OF THE USED COMPLAINT DEVICE CONFIRMS A LEAK NEAR THE PROXIMAL BOND. THE DEVICE IS ALSO PROVIDED WITH INSTRUCTIONS FOR USE WHICH INCLUDES INFORMATION REGARDING RUPTURES. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A CAUSE FOR THIS EVENT COULD NOT BE ESTABLISHED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER: K130293. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED, A (B)(6) MALE WAS UNDERGOING AN INTERVENTION OF THE LEFT SUPERFICIAL FEMORAL ARTERY FROM THE RIGHT GROIN. THE PATIENT'S VASCULATURE WAS DESCRIBED AS SEVERELY CALCIFIED BUT NOT TORTUOUS OR ANGLED. THE PHYSICIAN INFLATED THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER FOR 30 SECONDS AND DEFLATED ONCE USING A 70/30 MIXTURE OF OMNIPAQUE 350 CONTRAST TO SALINE. THE PHYSICIAN MOVED THE COMPLAINT BALLOON TO AN UNSPECIFIED AREA AND ATTEMPTED A SECOND INFLATION. IT WAS NOTED THE BALLOON WOULD NOT FULLY INFLATE. INFLATION PRESSURE WAS REPORTED TO BE 8 ATMOSPHERES (ATM). THE PHYSICIAN DEFLATED THE BALLOON AND NOTICED BLOOD IN THE COOK INFLATION DEVICE. IT WAS SUBSEQUENTLY DETERMINED THE BALLOON RUPTURED AND IT WAS REMOVED THROUGH THE ANSEL SHEATH. ANOTHER MANUFACTURER'S .018 GUIDE WIRE WAS OVER THE BALLOON. THE PATIENT WAS NOT HARMED AND DID NOT REQUIRE ANY ADDITIONAL INTERVENTION. NO PORTION OF THE BALLOON REMAINED IN THE PATIENT'S ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153212 ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INC G30964 7470782 10827002309644

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR