BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINDFRAME CAPTURE LP

    MDR report key: 4929827 · Received July 21, 2015

    Report

    Report Number
    2029214-2015-00818
    Event Type
    Injury
    Date Received
    July 21, 2015
    Date of Event
    June 22, 2015
    Report Date
    May 24, 2018
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    NRY
    PMA / PMN Number
    K141516
    Removal / Correction Number
    Z-1701-2018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROXIMAL SEGMENT OF THE PUSHWIRE WAS RETURNED FOR EVALUATION AND THE CLINICAL OBSERVATION WAS CONFIRMED. THE BROKEN END OF THE PUSHWIRE WAS SENT OUT FOR SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS. PER SEM, THE WIRE BROKEN END MORPHOLOGY WAS CONSISTENT WITH TENSILE OVERLOAD. IT IS POSSIBLE THAT THE TORTUOUS ANATOMY AND RESISTANCE MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE, SUBSEQUENTLY CAUSING THE PUSHWIRE SEPARATION. THE CLINICAL OBSERVATION WAS CONFIRMED. THROUGH ADDITIONAL FOLLOW WITH THE CUSTOMER IT WAS IDENTIFIED THAT THERE WAS FRICTION (RESISTANCE) OBSERVED DURING THE PROCEDURE AND DEVICE DELIVERY. OUR INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION: ¿IF EXCESSIVE RESISTANCE IS ENCOUNTERED DURING THE DELIVERY OF THE MINDFRAME CAPTURE LP, DISCONTINUE THE DELIVERY AND IDENTIFY THE CAUSE OF THE RESISTANCE. ADVANCEMENT OF THE MINDFRAME CAPTURE LP AGAINST RESISTANCE MAY RESULT IN DEVICE DAMAGE AND/OR PATIENT INJURY.¿ (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE. THE LOT HISTORY RECORD OF THE REPORTED LOT NUMBER HAS BEEN REVIEWED AND NO QUALITY ISSUES WERE NOTED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: TYPE OF REPORT, FOLLOW-UP TYPE, AND REMEDIAL ACTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED INFORMATION THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE OF THE LEFT M2 MIDDLE CEREBRAL ARTERY, IT WAS REPORTED THAT THE CAPTURE LP PUSHWIRE SEPARATED AS IT WAS BEING RETRIEVED AND REMAINS IN THE LEFT MCA (MIDDLE CEREBRAL ARTERY). PRIOR TO THE INCIDENT, THE CAPTURE LP WAS PLACED INTO THE THROMBUS, BUT IT WAS UNABLE TO BE REMOVED. THE PATIENT¿S ANATOMY WAS MODERATE IN TORTUOSITY. THE DEVICE WILL NOT BE REMOVED FROM ITS CURRENT LOCATION. THE PATIENT WAS NOT INJURED AND IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473012 MINDFRAME CAPTURE LP CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE) 300012 130108-002

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other| S