BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    MDR report key: 7046589 · Received November 20, 2017

    Report

    Report Number
    1820334-2017-04007
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Report Date
    February 22, 2018
    Manufacturer
    COOK INC
    Product Code
    PNO
    UDI-DI
    10827002352503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE DEVICE WAS RETURNED WITH BIOMATTER PRESENT. THE BALLOON WAS SEPARATED FROM THE DISTAL JOINT. THE BALLOON WAS STILL CONNECTED AT THE PROXIMAL END. THE CATHETER OUTER DIAMETER MEASURED WITHIN SPECIFICATION. THE LENGTH OF THE DISTAL TIP COULD NOT BE OBTAINED BECAUSE THE TIP WAS LIKELY DISTORTED DURING SEPARATION OF THE BALLOON MATERIAL FROM THE CATHETER. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. NUMEROUS DESIGN VERIFICATION AND VALIDATION ACTIVITIES HAVE BEEN PERFORMED TO ENSURE THAT THIS DEVICE MEETS DESIGN REQUIREMENT, EACH BALLOON IS 100% INSPECTED AND VERIFIED PRIOR TO RELEASE. REVIEW OF THE DEVICE HISTORY RECORD SHOWS NON-CONFORMING EVENTS; HOWEVER, ALL NON-CONFORMING PRODUCT WAS SCRAPPED OR REWORKED PRIOR TO COMPLETION OF THE FINAL LOT. IN ADDITION, THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED DEVICE, AND THE RESULTS OF OUR INVESTIGATION; THE ROOT CAUSE HAS BEEN DETERMINED TO BE RELATED TO USER TECHNIQUE, AS THE FACILITY REPORTED THE BALLOON WAS INFLATED NON-TRADITIONALLY. PER THE RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    COMMON NAME: CATHETER, PERCUTANEOUS, CUTTING/SCORING; PRODUCT CODE: PNO. PMA/510(K) NUMBER = K141322. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TESTING THE ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER WITH A SYRINGE TO OBSERVE THE PATTERN OF BURST, THE END OF THE BALLOON DETACHED FROM THE CATHETER. IT WAS NOTED THAT THE BALLOON INFLATED IN A "NON TRADITIONAL" MANNER. THE BALLOON CATHETER DID NOT COME INTO CONTACT WITH A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826393 ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER PNO COOK INC G35250 10827002352503

    Patients

    Seq Age Sex Outcome Treatment
    1