BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORMULA 414 RX BALLOON-EXPANDABLE STENT

    MDR report key: 6359996 · Received February 27, 2017

    Report

    Report Number
    3002808486-2017-00649
    Event Type
    Malfunction
    Date Received
    February 27, 2017
    Date of Event
    February 7, 2017
    Report Date
    February 10, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    NIN
    UDI-DI
    10827002037448
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE UNUSED DEVICE WAS RETURNED IN AN OPENED TYVEK POUCH, BUT WITH THE PROTECTIVE SLEEVE STILL PLACED OVER THE STENT AT THE DISTAL TIP. ACCORDING TO THE INSTRUCTIONS FOR USE THE PROTECTIVE SLEEVE MUST BE REMOVED DURING PREPARATION AND THE PRESENCE OF THE SLEEVE MAY HAVE CAUSED THE DIFFICULTIES WHEN ATTEMPTING TO ADVANCE THE FORMULA INTO THE SHEATH VALVE AND THE STENT TO "NOT GO FURTHER." IFU, PREPARATION OF BALLOON CATHETER: REMOVE THE FORMULA 414 RX VASCULAR STENT SYSTEM FROM THE PACKAGE, REMOVE PROTECTIVE SLEEVE FROM THE DISTAL TIP OF THE CATHETER AND INSPECT THE STENT TO ENSURE IT HAS NOT BEEN DAMAGED. INVESTIGATION REVEALED NO EVIDENCE TO SUGGEST THE FORMULA DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P100028. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THEY ADVANCED THE FORMULA THROUGH THE SHEATH AND HALFWAY THE VALVE THE BALLOON EXPANDABLE STENT DID NOT GO FURTHER. WITH THE SECOND 6 FRENCH SHEATH, THEY HAD THE SAME PROBLEM. EVENTUALLY THEY TOOK ANOTHER SHEATH FROM ANOTHER FIRM AND THE STENT WAS PLACED AFTER ALL. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THEY ADVANCED THE FORMULA THROUGH THE SHEATH AND HALFWAY THE VALVE THE BALLOON EXPANDABLE STENT DID NOT GO FURTHER. WITH THE SECOND 6 FRENCH SHEATH, THEY HAD THE SAME PROBLEM. EVENTUALLY THEY TOOK ANOTHER SHEATH FROM ANOTHER FIRM AND THE STENT WAS PLACED AFTER ALL. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143489 FORMULA 414 RX BALLOON-EXPANDABLE STENT WLQ BALLOON STENT NIN WILLIAM COOK EUROPE 10827002037448

    Patients

    Seq Age Sex Outcome Treatment
    1