BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    MDR report key: 7222702 · Received January 26, 2018

    Report

    Report Number
    1820334-2018-00333
    Event Type
    Malfunction
    Date Received
    January 26, 2018
    Date of Event
    January 24, 2018
    Report Date
    April 23, 2018
    Manufacturer
    COOK INC
    Product Code
    DQY
    UDI-DI
    10827002352527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION: A REVIEW OF THE DIMENSIONAL VERIFICATION, COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, DRAWING, QUALITY CONTROL, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE TWO RETURNED DEVICES CONFIRMED THAT THE BALLOONS HAD RUPTURED LONGITUDINALLY; HOWEVER, NEITHER HAD VISIBLE DAMAGE TO THE BALLOON BONDS OR CATHETER SHAFT. 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. A COMPLAINT HISTORY SEARCH REVEALED TWO COMPLAINTS TO BE ASSOCIATED WITH THE COMPLAINT LOT NUMBER 8316798; HOWEVER, THE OTHER ASSOCIATED COMPLAINTS WERE FOR BALLOONS THAT WOULD NOT INFLATE. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE WAS FOUND TO BE USER ERROR. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    COMMON NAME = CATHETER, PERCUTANEOUS, CUTTING/SCORING; PRODUCT CODE = PNO. PMA/510(K) NUMBER = K141322. (B)(4). 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 THAT DURING A FISTULAPLASTY, TWO ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETERS (LOT NUMBER 8316798) RUPTURED AT INFLATION PRESSURES OF 20 AND 22 ATMOSPHERE (ATM). ANOTHER MANUFACTURER'S INFLATION HANDLE WAS USED FOR EACH CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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
    67016 ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER DQY COOK INC G35252 10827002352527

    Patients

    Seq Age Sex Outcome Treatment
    1