BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSURE WIRE AERIS G8

    MDR report key: 6045506 · Received October 20, 2016

    Report

    Report Number
    3008452825-2016-00142
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    September 26, 2016
    Report Date
    September 26, 2016
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    DXO
    PMA / PMN Number
    K131452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION CONCLUDED THE COREWIRE WAS FRACTURED INTO TWO SECTIONS AT THE DISTAL TIP. THE TIP COIL HAD BEEN FRACTURED AND SEPARATED FROM THE WELD JOINT. THE PROXIMAL SECTION OF THE COREWIRE HAD BEEN KINKED. THE COMBINED LENGTH OF THE TWO COREWIRE SECTIONS INDICATED A PORTION OF THE COREWIRE WAS NOT RETURNED FROM THE DISTAL TIP ASSEMBLY. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE INCIDENT WAS DUE TO AN INTRINSIC DEFECT IN THE RETURNED DEVICE. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING SJM MANUFACTURING FACILITIES AS SUPPORTED BY A REVIEW OF THE DEVICE HISTORY RECORD. THE CAUSE OF THE TIP COIL AND COREWIRE DAMAGE IS CONSISTENT WITH FORCIBLE CONTACT DURING USE. THE PRESSUREWIRE INSTRUCTIONS FOR USE (IFU) STATES THAT EXCESSIVE MANIPULATION OF THE PRESSUREWIRE WHEN THE SENSOR ELEMENT OR PRESSUREWIRE TIP IS LOCATED IN SHARP BEND MAY CAUSE DAMAGE OR TIP FRACTURE. THE PRESSUREWIRE INSTRUCTIONS FOR USE (IFU) STATES THAT TORQUEING THE PRESSUREWIRE AGAINST RESISTANCE OR REPEATED ATTEMPTS TO CROSS A TOTAL VESSEL OCCLUSION MAY CAUSE DAMAGE AND/OR FRACTURE, WHICH MAY LEAD TO A PORTION OF PRESSUREWIRE SEPARATING FROM THE TIP.

    Description of Event or Problem · 1

    THE PRESSUREWIRE AERIS WAS BEING REMOVED FROM THE RCA WHEN THE PORTION OF THE PRESSUREWIRE DISTAL TO THE PRESSURE SENSOR BROKE OFF AND BECAME STUCK IN THE VESSEL. THE SEPARATION OCCURRED IN A PROCEDURE WHERE A NON-SJM GUIDEWIRE HAD BEEN INSERTED INTO THE VESSEL FOR PCI. THE TIP WAS REMOVED FROM THE PATIENT USING A SNARE. IT WAS REPORTED THAT THE PRESSUREWIRE WAS IN A VERY SMALL SIDE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696263 PRESSURE WIRE AERIS G8 TRANSDUCER, PRESSURE,CATHETER TIP DXO ST. JUDE MEDICAL, COSTA RICA LTDA C12058 5425379

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention