BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA CAT6 135CM INDIGO STRAIGHT TIP SYSTEM ASPIRATION CATHETER

    MDR report key: 7784288 · Received August 14, 2018

    Report

    Report Number
    MW5079144
    Event Type
    Malfunction
    Date Received
    August 14, 2018
    Date of Event
    August 7, 2018
    Report Date
    August 13, 2018
    Manufacturer
    COVIDIEN
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT RETURNED TO CATH LAB S/P EKOS. EKOS CATHETER REMOVED FROM EXISTING 6F PINNACLE SHEATH. QUICKCROSS CATHETER WAS INSERTED OVER THE WHOLEY WIRE AND IMAGING PERFORMED. CAT6 PENUMBRA 6F, 135 CM STRAIGHT TIP THROMBECTOMY CATHETER WAS INSERTED OVER THE WHOLEY GUIDEWIRE 260 CM X 0.089 CM. THERE WAS DIFFICULTY ADVANCING THE CATHETER. MD ATTEMPTED TO REMOVE THE CATHETER WITH SOME RESISTANCE. UPON REMOVAL, THE CATHETER APPEARED TO UNRAVEL LEAVING A PORTION OF THE CATHETER IN THE LOWER EXTREMITY (BELOW THE KNEE). MULTIPLE ATTEMPTS MADE TO RETRIEVE, BUT WERE UNSUCCESSFUL. PROCEDURE WAS ABORTED WITH FOREIGN BODY REMAINING IN THE BODY. WHOLEY WIRE REF # (B)(4), LOT #10859837, EXP DATE: 01/06/2020, COVIDIEN LLC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621016 PENUMBRA CAT6 135CM INDIGO STRAIGHT TIP SYSTEM ASPIRATION CATHETER CATHETER AND TIP SUCTION JOL COVIDIEN F81583

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other