BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    MDR report key: 7129599 · Received December 19, 2017

    Report

    Report Number
    1820334-2017-04489
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    December 12, 2017
    Report Date
    January 24, 2018
    Manufacturer
    COOK INC
    Product Code
    PNO
    UDI-DI
    10827002352534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    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 ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER WAS RETURNED FOR INVESTIGATION. BOTH MARKER BANDS ARE PRESENT. NO DAMAGE NOTED TO THE CATHETER. THE BALLOON HAD A LONGITUDINAL RUPTURE. THE BALLOON LENGTH MEASURED WITHIN SPECIFICATIONS. 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 OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS FOR THIS LOT NUMBER. IN ADDITION, THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS POSSIBLE THAT THE BALLOON DAMAGE COULD BE ATTRIBUTED TO PATIENT ANATOMY, AS THE CUSTOMER STATED, THERE "MAY HAVE BEEN CALCIFICATION". 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ILIAC OCCLUSION PREPARATION FOR A STENT, THE ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER RUPTURED AFTER BEING SLOWLY INFLATED TO 10 ATMOSPHERE (ATM). THE ACCESS SITE USED WAS THE PATIENT'S FEMORAL ARTERY. A NEW BALLOON CATHETER WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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
    911613 ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER PNO COOK INC G35253 10827002352534

    Patients

    Seq Age Sex Outcome Treatment
    1