BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    MDR report key: 7224429 · Received January 29, 2018

    Report

    Report Number
    1820334-2018-00200
    Event Type
    Malfunction
    Date Received
    January 29, 2018
    Date of Event
    January 19, 2018
    Report Date
    April 24, 2018
    Manufacturer
    COOK INC
    Product Code
    PNO
    UDI-DI
    10827002352527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: A REVIEW OF THE DIMENSIONAL VERIFICATION, COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, SPECIFICATIONS, AND A VISUAL INSPECTION AND FUNCTIONAL EVALUATION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE NOTED NO SURFACE DEFECTS OF THE CATHETER OR BALLOON. DURING THE FUNCTIONAL EVALUATION OF THE DEVICE, THE BALLOON INFLATED BUT WOULD NOT REMAIN INFLATED. THE BALLOON ITSELF DID NOT LEAK, BUT THE DISTAL TIP OF THE CATHETER DID. CROW¿S FEET WERE PRESENT ON THE BALLOON. 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 DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED.

    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 TREATMENT OF A POPLITEAL ARTERY STENOSIS VIA THE FEMORAL ARTERY, THE ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER LONGITUDINALLY RUPTURED DURING DILATATION. IT WAS NOTED THAT THE PATIENT'S POPLITEAL ARTERY WAS ANGULATED AND CALCIFIED. BLOOD WAS BEING DIRECTLY ASPIRATED; THE BALLOON WAS NOT BEING INFLATED DURING THE EVENT. ANOTHER MANUFACTURER'S 7 FR SHEATH, AND A WIRE GUIDE WERE IN PLACE. 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
    68170 ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER PNO COOK INC G35252 10827002352527

    Patients

    Seq Age Sex Outcome Treatment
    1