BEUDAMED
    FDA Adverse Event Other Summary report: N

    OVER-THE-WIRE EMBOLECTOMY CATHETER

    MDR report key: 2771721 · Received September 26, 2012

    Report

    Report Number
    1220948-2012-00013
    Event Type
    Other
    Date Received
    September 26, 2012
    Date of Event
    August 28, 2012
    Report Date
    September 2, 2012
    Manufacturer
    LEMAITRE VASCULAR INC
    Product Code
    DXE
    PMA / PMN Number
    K022145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE DEVICE FOR EVALUATION A ND WERE ABLE TO CONFIRM THE FAILURE: THE TIP OF THE CATHETER WAS DETACHED. ADDITIONALLY, THE LUMEN OF THE CATHETER WAS STRETCH/ELONGATED. THE MOST PROBABLE ROOT CAUSE OF THE FAILURE IS FROM EXCESSIVE FORCE USED DURING THE PROCEDURE. THE LEMAITRE VASCULAR IFU WARNS TO EXERCISE CAUTION WHEN ENCOUNTERING EXTREMELY DISEASED VESSELS AND AVOID USING EXCESSIVE FORCE TO PUSH OR PULL CATHETER AGAINST RESISTANCE. THE PHYSICIAN DID NOT TAKE INTO CONSIDERATION THESE WARNING WHILE HE PERFORMED THE PROCEDURE. A LOT HISTORY INVESTIGATION WAS PERFORMED. THE DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT DURING THE MANUFACTURING AND PACKAGING PROCESSES AND THERE WERE NO UNRESOLVED ISSUES RELATED TO THE COMPLAINT EVENT. IN ADDITION, PLEASE NOTE THAT THE PT IS OKAY.

    Description of Event or Problem · 1

    THE PHYSICIAN PERFORMED THROMBECTOMY. THE PHYSICIAN FELT UNK RESISTANCE WHEN HE PULLED THE CATHETER WITH THE INFLATED BALLOON (PERFORMED THROMBECTOMY). THE TIP OF THE CATHETER (THE BALLOON AREA) WAS DETACHED WHEN THE SURGEON PULLED THE CATHETER OUT OF THE PT. THE TIP OF THE CATHETER WAS SUBSEQUENTLY REMOVED FROM THE PT ON (B)(6) 2012. THE PT IS RECOVERED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVER-THE-WIRE EMBOLECTOMY CATHETER DUAL LUMEN EMBOLECTOMY CATHETER DXE LEMAITRE VASCULAR INC NA OTW2017 OR OTW2035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other