BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM SEPARATOR 8

    MDR report key: 6056162 · Received October 25, 2016

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    Report

    Report Number
    3005168196-2016-01513
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    September 25, 2016
    Report Date
    September 26, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00814548016153
    PMA / PMN Number
    K161523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    PMA/510(K)# HAS BEEN UPDATED TO REFLECT THE MOST CURRENT 510(K) # FOR THE DEVICE AT THE TIME OF THE REPORTED COMPLAINT. RESULTS: THE INDIGO SYSTEM SEPARATOR 8 (SEP8) CORE WIRE WAS FRACTURED APPROXIMATELY 148.5 CM FROM THE PROXIMAL END. THE SEP8 BULB WAS STILL INTACT WITH THE COIL WINDINGS OF THE SEP8. THE SEP8 COIL WINDINGS WERE SEPARATED BY THE INVESTIGATOR FOR FURTHER EVALUATION. THE DISTAL SEGMENT OF THE FRACTURED CORE WIRE WAS INTACT WITH THE DISTAL TIP OF THE BULB TO THE DISTAL SOLDER JOINT. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE CORE WIRE TO THE SEP8 WAS FRACTURED PROXIMAL TO THE BULB. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING USE. IF THE SEP8 IS WITHDRAWN FORCEFULLY AGAINST RESISTANCE, DAMAGE SUCH AS THIS MAY OCCUR. SEP8 DEVICES ARE VISUALLY INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A PULMONARY EMBOLISM (PE) USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA SHEATH IN THE LEFT CORONARY ARTERY AND THEN USED AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) WITH THE SEP8 TO REMOVE THROMBUS. AFTER USING THE SEP8 WITH THE CAT8 FOR SEVERAL PASSES, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SEP8 BECAME STUCK IN THE CAT8 AND WOULD NOT MOVE FORWARD OR BACKWARD. THEREFORE, THE CAT8 WITH THE SEP8 STILL INSIDE OF IT WAS REMOVED FROM THE PATIENT'S BODY. WHILE THE DEVICES WERE ON THE BACK TABLE, THE PHYSICIAN REMOVED THE SEP8 FROM THE CAT8 AND NOTICED THAT THE WIRE IN FRONT OF THE SEP8 BULB APPEARED TO BE FRACTURED AND UNWINDING. THE PROCEDURE WAS THEN COMPLETED USING A NEW SEP8 AND THE SAME CAT8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705098 INDIGO SYSTEM SEPARATOR 8 DXE DXE PENUMBRA, INC. F66926 00814548016153

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR