BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 6713462 · Received July 14, 2017

    Report

    Report Number
    1820334-2017-01726
    Event Type
    Malfunction
    Date Received
    July 14, 2017
    Date of Event
    June 19, 2017
    Report Date
    October 16, 2017
    Manufacturer
    COOK INC
    Product Code
    DQY
    UDI-DI
    10827002522524
    PMA / PMN Number
    K091527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: PMA/510(K) #: K091527 INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), SPECIFICATIONS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE USED ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS RETURNED IN A DAMAGED CONDITION. BIO-MATERIAL WAS CLEARED FROM LUMEN ATTEMPT WAS MADE TO INFLATE THE BALLOON, A PINHOLE WAS NOTED AT THE PROXIMAL END OF THE BALLOON. THE LENGTH OF THE DEVICE WAS WITHIN SPECIFICATIONS. THE BALLOON LENGTH OF THE DEVICE WAS WITHIN SPECIFICATIONS. THERE WAS NO DAMAGE NOTED TO THE CATHETER. THE BALLOON DID NOT BURST LONGITUDINALLY OR CIRCUMFERENTIALLY. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE BALLOON IS 100% INSPECTED AND VERIFIED PRIOR TO RELEASE. THERE IS NO MENTION OF CALCIFICATIONS OR OTHER HUMAN ANATOMY CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE DEVICE FAILURE. THERE IS NO MENTION OF PREPARATION OF THE DEVICE PRIOR TO PATIENT CONTACT THAT MAY HAVE CONTRIBUTED TO THE DEVICE FAILURE. THE DEVICE DID NOT RUPTURE. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING 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

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    A FISTULOGRAM WAS BEING PERFORMED VIA THE UPPER ARM OF A PATIENT, AND A PHYSICIAN WAS USING A LOW PROFILE BALLOON CATHETER WITH EQUAL PARTS ISOVIEW 300 AND SALINE. IT WAS REPORTED THAT DURING THE PROCEDURE THE BALLOON BURST AT LOWER THAN THE BURST PRESSURE. WHEN ASKED WHAT THE INFLATION PRESSURE WAS, IT WAS PROVIDED BY THE COMPLAINANT THAT THEY WERE "NOT SURE BUT BELOW BURST PRESSURE." NO ADVERSE EFFECTS WERE REPORTED PRIOR TO THE OCCURRENCE, AND NO ADDITIONAL PROCEDURES WERE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493926 ADVANCE 35 LP LOW PROFILE BALLOON CATHETER DQY CATHETER, PERCUTANEOUS DQY COOK INC G52252 10827002522524

    Patients

    Seq Age Sex Outcome Treatment
    1